Europeans Try to Track and Trace Pharmaceuticals
The Italian government will soon unveil the first phase of a drug-tracking system designed to trace individual bottles of prescription medicine-using bar code labels that have unique serial numbers—from production to the consumer. It will require drug manufacturers, wholesalers and retail stores to report sales data to the Italian Ministry of Health within 24 hours of a transaction. Health authorities will compare all the sales data—as well as compare the data with epidemiological information—to help prevent counterfeiting, theft and other actions that could threaten public health.

But Italian pharmaceutical industry groups complain that the program—which is based on a dual bar coding system they call the bollino—will be difficult for the industry to implement because high-volume bar code readers haven't been developed yet to scan and capture thousands of serial numbers per hour. Using the current bar code scanners would slow productivity. A working group made up of government and industry representatives will be formed later this year to look into subsequent phases of implementation and possible tests of alternative technologies, including RFID.

"If you want to really monitor along the supply chain, every transaction, I'm convinced the bar code technology is not the correct one," says Stefano Novaresi, chief operating officer of the Comifar Group, Italy's largest drug wholesaler, and a board member of the Associazione Distributori Farmaceutici, the Italian wholesaler's association. "In this sense, a technology like RFID, when the performance in terms of reading speed and error rate will be adequate, could be a concrete answer to the problem."

Nevertheless, the Italian government's plan to track pharmaceuticals is the most advanced in Europe. In other countries, the pharmaceutical industry, which is concerned about the possible impact of counterfeit products on public health and dilution of their brands, is taking the reigns.

GlaxoSmithKline, based in Middlesex, England, has plans within the next year to put RFID tags on certain pharmaceutical products it deems susceptible to counterfeiting or theft. GSK has identified several top priority drugs as candidates for its pilot, including Combivir, Epivir, Retrovir, Trizivir, Ziagen and Zofran. GSK has already started tagging some pallets and cases of consumer healthcare products that it ships to Wal-Mart's distribution center in Texas and to Metro, a German retailer.

In March, British technology provider Aegate reported that a three-month trial aimed at validating prescription drugs at the point of dispensing was successful. During the pilot, 180,000 bottles of medicine—about 20,000 different products—were tracked from their manufacture to their dispensing in 44 pharmacies across England and Wales. The bottles were labeled with a serial number, either on a bar code or on an RFID tag. Pharmacists checked that the numbers matched up with those on a secure database before selling drugs to customers. Six drug manufacturers participated, including Merck Generics UK, Merck Pharmaceuticals, Novartis, Schering Health Care and Solvay.

Two additional European pilots will start later this year. Both projects are sponsored by a division of the GS1—the successor to the Association for European Article Numbering (EAN), the counterpart to the U.S. UPC code. One pilot is an extension of the GS1 European Healthcare Initiative (EHI) to spread standard ways of identifying and bar coding pharmaceuticals throughout Europe. The second pilot will track both branded and generic drugs through the supply chain using bar codes and EPC numbers at all levels of packaging, according to John Jenkins, an EHI spokesperson. A global pharmaceutical manufacturer—Jenkins declined to provide the name of the company—will apply the bar code and RFID labels by machine, and the products will be traced throughout the supply chain.