Authentication Before Track and Trace

Daphne Allen, Editor

Pfizer is directing pharmacies to SupplyScape's RxAuthentication Service to authenticate Viagra. (click image to enlarge)

All bottles, cases, and pallets of Viagra (sildenafil citrate) are now shipping to the United States with radio-frequency identification (RFID) tags. According to Pfizer, Viagra was chosen because “it has been a major target for counterfeiters.” The tags carry Electronic Product Codes, and they are backed up with redundant Datamatrix 2-D bar codes.

“The primary goal for adding the technology is to enhance patient safety,” says Tom McPhillips, vice president of Pfizer’s U.S. Trade Group, in a press release. “We want pharmacists who fill prescriptions for Pfizer medicines, and patients who use those medicines, to have increased confidence that they are receiving authentic product and not a potentially dangerous fake. We are creating additional barriers for criminals who might attempt to counterfeit our products.”

Given the breadth of packages, the project is a significant endeavor. According to Dave DeJean of Systech International (Cranbury, NJ), which provided its TIPS Serialized Product Tracking solution to Pfizer for the project, “100% of product is being tagged, and those tags are being encoded on the line at typical production speeds.” The bottles carry high-frequency 13.56-MHz tags incorporated into the manufacturer’s labels, and ultrahigh-frequency (UHF) 915-MHz are affixed to cases and pallets.

Tagsys (Doylestown, PA) provides the item-level Flexible Module (FM) HF tags that are employed for bottle labeling. “FM tags are small (measuring 11¼ × 5¼ in.) and flexible, and they can be read in dense packaging configurations containing numerous tightly packed bottles,” explains John Jordon, president of worldwide field operations for Tagsys. The write-once, read-many (WORM) tag encodes the EPC, which includes serialization, vital for epedigree initiatives. Pfizer chose an open protocol that can be read by any Philips I-Code capable reader, Jordon says.

Pfizer is using Tagsys's Flexible Module HF tags.

In 2006, Pfizer will be focusing on RFID tag quality, working with Tagsys and the label converter, CCL Label, to increase RFID label quality. “Initial testing by Pfizer Global Technology indicates results for field readability and reliability should be quite good,” says Timothy Marsh, technology manager, global package technology, for Pfizer Global Technology (North Peapack, NJ). “Only time will tell, however.”

Marsh says that Pfizer “felt quality levels were sufficient to launch when compared against certain project objectives.” For example, Pfizer did not have to slow the production line down in order to be able to encode online. “It’s as much an educational endeavor for Pfizer as it is a pilot in promotion toward greater patient safety. This pilot is showing us first-hand how to scale and deploy the technology to additional products and manufacturing and distribution environments should we decide to do so,” he says.

Redundancy and verification are staples of the program. “Our TIPS system tracks all packages and tags on the line,” says DeJean. “As soon as a tag is encoded, TIPS verifies it and directs a laser to print the redundant Datamatrix code, and then the RFID tag and code are matched and verified again,” says DeJean. All parent-to-child relationships between bottles and cases and cases and pallets are tracked and archived.

TIPS then exports all data to software from SupplyScape (Woburn, MA). The SupplyScape RxAuthentication Service receives “commissioning data from Pfizer, informing the system that a certain group of EPCs exists and is associated with certain NDCs, tracking parent to child relationships,” explains Dan Walles, program manager for SupplyScape. “We have been getting such data from Pfizer for months.”

RFID implementation took place in less than one year. “We first made contact with Pfizer in February 2005, after they had read our white paper on HF tags for item-level packages with Texas Instruments,” says Tagsys’ Jordon. “We went live in December 2005. Pfizer has done a phenomenal job.”

Marsh says that Pfizer’s success has a lot to do with the fact that Pfizer team leaders “were empowered to make decisions quickly in an entrepreneurial manner. We held each supplier accountable and redirected as necessary to achieve the greater goal. It all seems like it was very easy at this point, but it’s important to remember there was a good bit of hard design work and compromise by Pfizer team leaders associated with the phases.” He adds that the teams learned some lessons from the Wal-Mart RFID UHF case and pallet launch in 2004.

Pfizer is working on a program that will help pharmacies and wholesalers adopt systems to authenticate the EPCs. Pfizer is directing registered pharmacists and wholesalers through a portal at its Web site to the SupplyScape RxAuthentication Service to authenticate EPCs in real time. Pharmacists can scan bar codes or read RFID tags and submit the EPC data to the RxAuthentication Service. The system generates a “Results” page verifying that Pfizer has issued and shipped products with those EPCs and that those EPCs are valid. Shipping transaction information is provided, reporting, for instance, the intended destination for certain EPCs. “The system provides a level of supply chain visibility that hasn’t been there before,” says Walles.

Jordon reports that Tagsys is selling readers and antennas to pharmacies and wholesalers.

However, Pfizer “anticipates that it will take several years before RFID is applied broadly throughout the pharmaceutical industry,” it says in a press release. “Cost will be a significant consideration, as well as the readability and reliability of RFID tags. Standards must be developed to govern technology and data exchange. And RFID also will require the pharmaceutical distribution industry to change the way it does business.”

Until all channels in the supply chain utilize RFID technology and “agree to capture and share information about product movement,” Pfizer cannot “track and trace” Viagra throughout the entire system. Pfizer is working with standards-setting bodies, state governments, FDA, industry groups, and its customers to establish policies for the widespread application of RFID in the future.

HK Systems (Milwaukee, WI) played a critical role in Pfizer’s RFID implementation at its distribution centers, says Peggy Staver, Pfizer’s director of trade product integrity.

RFID “will help deter counterfeiting, though it is not a solution unto itself,” says Rich Hollander, senior director of packaging services for Pfizer.
Adds a Pfizer spokesperson: “The problem must be addressed on many different fronts, including tightening state regulations for the licensing and distribution of pharmaceutical products, modifying business practices, increasing enforcement, and using technology effectively.”