RFID, Other Technologies Offer Various Solutions to Counterfeit Drugs

Radio frequency identification (RFID) product tags have long been touted as a panacea for the problem of counterfeit and gray market drugs, but other technologies — both familiar and new — can also offer protection, according to specialists at a recent industry convention.

Making the case for RFID, one expert noted the technology addresses major problems faced by the pharma industry, including product diversion onto the gray market and product recalls. With RFID “you can do targeted recalls because you have supply chain visibility,” Paul Chang, associate partner of IBM Business Consulting Services, told Interphex conference attendees March 22.

Companies that have had well-publicized problems with product authentication are jumping on the RFID bandwagon, Chang noted. “Pfizer is tagging one hundred percent of Viagra — five SKUs [stock keeping units] — because it’s one of the most counterfeited drugs in the world,” he said. “Purdue Pharmaceuticals is tagging one hundred percent of Oxycontin for Wal-Mart.”

Even more important is the potential to use RFID as an electronic pedigree for drugs, others say. Four states — California, Indiana, Arizona and Florida — have instituted requirements for drug pedigrees, although Florida does not currently require the pedigree to be electronic, Jeff Schaengold of Siemens said in another conference session. Florida will, however, be the first to implement an electronic pedigree starting July 1. Eleven other states are considering pedigree mandates, he added.

Other technology experts have pointed out the need to address privacy issues regarding RFID products. Privacy advocates have opposed the widespread use of RFID in drug packaging because it encodes such product-class information as specific dosage and quantity, noted Joseph Pearson, business development manager for Texas Instruments’ pharmaceutical RFID business.

Texas Instruments’ HF-I Pro has a feature designed to overcome these privacy concerns, Pearson told PIR. Using the HF-I Pro’s password-protected write feature, a wholesaler or retail pharmacist can “decommission” that data “when the product enters the retail distribution center, or when the prescription is filled,” he said.

In addition, Pearson stressed the importance of RFID to the implementation of electronic pedigrees in item-level tagging. “It’s not so much about the individual product but the entire case — for example, a block of all 72 products in the case. You can create a pedigree from the information stored in databases,” he said.

Pearson noted that both retailers and pharmaceutical manufacturers are working together through EPC Global, the umbrella organization responsible for UPC product codes, to advance RFID adoption.

But other experts point to the limitations of RFID technology. The “read rate” for RFID information is “more like 70 percent in reality” than the “99 percent plus” figure claimed by RFID advocates, said Kevin Harrell, director of global business development for Kodak subsidiary CREO. “In our work with Wal-Mart, we found a 30 to 35 percent [failure] rate,” Harrell said, adding that he was not out to disparage RFID technology.

Harrell is promoting the Kodak Traceless System as an alternative to RFID. The product uses “a unique image processing technology and undisclosed marker materials — as well as additional layers of proprietary technology — so that marker particles are randomly distributed on the item,” he said.

The client chooses where to place the marker particles on the package, information it does not have to disclose to Kodak. The client is required to lease, rather than buy, the detector equipment.

The particles are microscopic specks distributed in a random and non-duplicable fashion, like chocolate chips in cookies, Harrell said. However, these “chips” are between two and five parts per billion of the packaging material, making them “forensically and optically invisible.” The identification codes are generated from only about a dozen of these particles, which can be arranged in some three trillion unique combinations.

The technology could be used in the coatings of individual capsules, but FDA approval is years off, Harrell said.

Schaengold advocates using a combination of technologies along with RFID, such as 2D barcodes and human-readable serial numbers, so that customers can check corporate websites to learn whether their product is genuine.

The problem today, he said, is that “too many companies are starting with RFID, which is the most expensive part of the process, and then filling in the 2D barcode and the [serial] numbers.” The industry should take this technology one step at a time, Schaengold advised. — Martin Gidron