EFPIA updates on Swedish serialisation project at Pharmapack

The pharmaceutical serialisation pilot currently ongoing in Sweden is progressing smoothly, according to the European Federation for Pharmaceutical Industries and Associations (EFPIA).

Jean-Marc Bobée of Sanofi-Aventis, who is leading the project for EFPIA, told delegates at the Pharmapack conference in Paris earlier this week that the system is currently processing more than 1,000 medicine packs every day, with no operational problems being reported by pharmacists involved in the pilot.

The pilot involves the placement of a datamatrix code on each medicine pack, containing a product code, batch number, an expiry date and a randomised serial number by the wholesalers as they receive product from the manufacturer. 

The code is read in the pharmacy as the product is dispensed to the patient, and the systemt checks that a pack with that serial number has not been dispensed before. If it is already marked in the database as dispensed, the pharmacist is made aware of the possibility that the pack may be counterfeit and an alert is triggered. Scanning also provides an opportunity to check the product is still in shelf-life and has not been recalled.

The EFPIA scheme involves 25 Apoteket AB pharmacies in the Stockholm region and local wholesalers Tamro and Kronans Droghandel, with the information technology elements provided by Siemens. Pharmaceutical products from 14 manufacturers are included in the pilot, which will have scanned a total of 110,000 packs by the time it concludes.

Bobée said that the reading of the code by the pharmacists seems to be very reliable, with a 94 per cent successful read rate in less than 0.5 seconds, rising to 99.9 per cent in less than 2.0 seconds.

The four-month pilot got underway in September and is now in the closing stages.

With the pilot on course for a successful outcome, the next and more difficult step will be to persuade the European Commission and other stakeholders in the pharmaceutical industry to establish a single, EU-wide coding system that would allow such a system to be rolled out across the region.


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