EFPIA Working Toward a Unique Codification Standard in Europe

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has been driving industry commitment toward the increased protection of the drug supply chain. Over the last years, its priority has been to set up a common identification standard in Europe to secure drug distribution practices.

“Our action has been more intense lately considering the increasing rates of counterfeit medicines in Europe and the ongoing activities of parallel imports and repackaging,” notes Anthony Barron, coding and codification coordinator in Europe for EFPIA, which is based in Brussels, Belgium.

To improve safety, EFPIA recommends a set of measures to protect the drug supply chain, which includes the use of tamper-evident features or more sophisticated overt and covert technologies on packs, as well as the development of a harmonised coding and identification system for medicines allowing the unique verification of each medicine pack. This could be supported by the implementation of a Datamatrix code, which integrates four elements of identification: the GS1 Global Standard, the Global Trade Item Number (GTIN) or the National Identification Trade Number (NTIN), which is in line with the French CIP code; the expiry date; the batch number; and a randomised serial number. “Our unit traceability concept based both on Datamatrix and the GS1 Global Standard is not a track-and-trace system, but a systematic end-to-end detection process at the pharmacist scale,” explains Barron. At the end of the supply chain, the pharmacist simply has to scan and compare the serial numbers to the ones stocked into a global database, to identify whether any problem occurs during dispensing concerning drug use-by date, batch recalls, or fake products.

Last October, EFPIA launched a pilot project in Stockholm, Sweden, to test the technical and political feasibility of its end-to-end “point-of-dispense” concept. “Sweden was--at the time--a pharmacist state monopoly (Apoteket AB) with a centralised decision-making process, which made it easier and quicker to put in place our whole system, including IT software, within just over eight months time,” explains Barron. Concretely, 25 pharmacists and roughly 80 points of sale participated in the project. A total of 25 drug products, from 14 EFPIA member companies, were involved. In addition, the local wholesalers Tamro and Kronans Droghandel (KD) labelled the 110,000 folding boxes with Datamatrix codes. Then the pilot was spread over four months.

Today, the results of the study are good from a pharmacist perspective: the EFPIA system is easy and quick to use (less than one second for scan and verification), and it could be deployed without any additional efforts on a local level.

Based on the Swedish case, EFPIA recommends running a pilot phase for each deployment (region) so that defects can be eliminated before full rollout. In fact, Swedish pharmacists were already using their own control system for the identification of EAN code, which was maintained on boxes on request of the local government. “What we learn is when putting too many codes, we create confusion and increase human and scanning errors,” notes Barron. “In order to achieve sustained credibility, the system must provide the correct answers to all transaction requests, otherwise, the pharmacist simply will not trust the system to guarantee the safety of the patient.”

And now, what are the consequences for the industry and their packaging suppliers? “This is something that we are going to investigate from now on,” he adds. “Clearly, one consequence is that the repackaging activities will have to be more closely monitored, and the measures imposed on manufacturing be applied on a European scale.” These are the main legislative changes expected by the industry, which will stem from the upcoming European Directive aim at preventing drug counterfeiting, which should come into force early 2011.

This article was authored by Marion Baschet-Vernet, a freelance writer based in France. Images are courtesy of EFPIA

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