EFPIA serialization pilot project reaches successful operational conclusion

A test of putting random serial numbers on individual pharmaceutical packages, and then verifying their authenticity at retail pharmacies, successfully concluded its operational phase this week, according to officials of the European Federation of Pharmaceutical Industries Associations. The test, similar to the many pilots run for other technologies (such as RFID) for verifying the disposition of individual packages, is notable for being the only ongoing project that involves manufacturers (who supplied actual—not “test”—product), distributors (who did the labeling and physical distribution), and retail pharmacies—the end-to-end “normal” distribution chain that is the heart of many state-level pedigree programs in the US.

According to EFPIA sources, the pilot handled over 110,000 packages (representing 25 SKUs) during the September-January timeframe. Fourteen major biopharma companies were involved, two regional wholesalers, and 25 pharmacies in the Stockholm area of the Apoteket AB chain. Preliminary results will be discussed at two upcoming meetings: Reconnaissance International’s Pharma Global Forum on Anticounterfeiting (Miami, Feb. 24-26) and the CBI Anticounterfeiting and ePedigree conference (March 10-11, Philadelphia)

EFPIA is promoting the use of 2D barcodes as the preferred method of verifying product authenticity through the European pharma distribution system, and several European nations have adopted that method, at least in principle. However, there is no uniformity of barcode standards, and the onus is on retail pharmacies to perform the verifying scan at the distribution point. Later this spring, FDA is obligated to report on recommendations for serialization standards for US pharma distribution and—starting in 2015—California is still committed to establishing an e-pedigree system for distribution within that state (2009 Pharmaceutical Product Security Report, September, 2009).