EFPIA publishes serialisation pilot report

EFPIA counterfeit graphicThe European Federation of Pharmaceutical Industries and Associations (EFPIA) published its final report on the medicines serialisation pilot in Sweden today, indicating that the approach is "viable, proportionate, secure and cost-effective."

The report - available to download here - concludes that a product verification system at the point of dispense, based on a two-dimensional datamatrix, is "both robust and effective."

The pilot project scanned and verified almost 100,000 packs in 25 pharmacies across Stockholm, at the time of dispensing, in collaboration with pharmaceutical retail chain Apoteket AB. The project also had the support of pharmaceutical distributors Tamro and KD Pharma and the cooperation of LIF, the Swedish pharmaceutical manufacturers’ association. Packs from 14 manufacturers were provided with the 2D datamatrix, allowing each pack to be individually identified.

David Brennan, CEO of AstraZeneca,said: "This pilot has demonstrated that the proposed EFPIA model could offer a proportionate and cost-effective means to improve the security of medicines."

Key findings from the pilot include that the system provides for the effective identification of fake packs as well as expired or short dated packs and recalled products.

The pilot made use of 750 test packs - indicating product that had expired, was under recall or did not exist on the system and so was likely to be fake - and the system was able to pick up all these cases, according to the report.

There was also a clear need for packs to have only a single barcode, according to the report. Users were sometimes confused by the presence of more than one code on the pack.

Stefan Carlsson, CEO of Apoteket, said the system integrated well into the usual day-to-day operation of the pharmacies and would be valuable "for preventing counterfeits and for other management functions."

Related articles:

Pharmacists respond favourably to EFPIA's serialisation pilot

EFPIA updates on Swedish serialisation project at Pharmapack

Interim EU measures needed to stem counterfeits

Traceability of medicines in EU: feasible, but challenging

Sweden will host EFPIA serialisation project

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