Toolkit: Safety in Numbers

June 1, 2006

Pharmaceutical Executive

Volume 0, Issue 0

Scott Gottlieb called RFID implementation "disappointing." Now, FDA is moderating its view of RFID as a cure-all for the industry.

Back in 2004, the FDA was very optimistic about the timeline and development of Radio Frequency Identification (RFID) for use in tracking pharmaceuticals. "RFID...appears to be the most promising approach to reliable product tracking and tracing," the FDA report, "Combating Counterfeit Drugs," stated. By using tags with tiny radio transmitters to track drugs through the supply chain, RFID promised to drastically curb the growing problem of pharmaceutical counterfeiting and diversion. The FDA report went on to predict that companies would use RFID to track every case and pallet, and most units of drugs moving through the supply chain, by the end of 2007.

Jim Rittenburg

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.

In remarks made in March at the Parenteral Drug Association's Pharmaceutical Anti-Counterfeiting Forum, FDA Deputy Commissioner Scott Gottlieb called the progress made toward the implementation of RFID "disappointing." At press time, FDA was expected to issue an updated report—chances are, it will take a more moderated view of RFID as a near-term cure-all.

350 "Bollinis"

Meanwhile, in the United States, the problem of pharmaceutical counterfeiting shows no signs of abating. In 2003, FDA opened 30 investigations; in 2004, that number rose to 58 cases. Increased vigilance and awareness may explain the spike in the number of reported cases, but the problem of pharmaceutical counterfeiting is increasing as well. Every day it becomes easier to produce authentic-looking packaging and counterfeit products.

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.

Barcoding Benefits

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.

Mix and Match

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 jim.rittenburg@authentix.com