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Drug traceability, all subjects involved

Drug traceability is a relevant but delicate aspect of pharmaceutical management. It allows the univocal identification of each single pack of a medicinal product, protecting manufacturers from any frauds as well patients from dangerous counterfeiting. It is also essential to monitor medicine supplies to hospitals and pharmacies, and to have a full picture of drug consumption in Italy. Finally, it is a fundamental tool for pharmacovigilance, as it allows the detection of all handlings of the packs of medicines present on the market.

For a long time, drug traceability has been an exclusive Italian feature: this is based on the application of a machine-reading antifraud sticker, reporting all information about the medicine in two barcodes (an upper and a lower barcode), and in a datamatrix. The sticker, it should be noted, along with the name of the MA holder and medicinal products, the marketing authorisation number (MA) and a description of the presentation, also includes a progressive numbering of the sticker itself, thus attributing a univocal code to each pack.

When the rest of Europe also realised the importance of the serialisation of drugs for the safety of medicinal products, a system for the transmission of traceability data was implemented at European level. This became effective in February 2019. However, Italy obtained a waiver to comply with the European system as it had already its own traceability system in place.

Therefore, until 2025 (when the new European serialisation system will enter into effect also in Italy), traceability will still provide for the presence of a centralised Data Bank at the Ministry of Health, where the handlings of the single packs are recorded through the manufacturing and supply data of antifraud stickers.

However, in the complicated landscape of the European pharmaceutical market, at times it is difficult to understand who should be in charge of this data bank update. According to the relevant regulations, namely article 40 of Law 1st March 2002 no. 39, instituting the Data Bank, this task is to be carried out by all figures involved in the pharmaceutical supply chain, who shall record and transmit to the data bank all traceability information according to specific and well defined timetables.

Traceability is therefore an obligation of anyone taking part to the manufacturing and distribution of the concerned drug, starting from the manufacturer through the distributors and wholesalers up to pharmacies and hospitals. This also concerns the disposal of expired or unusable drugs.

If the application of the stickers on the packs is carried out by a secondary packaging site located in Italy, traceability is entrusted to the latter; on the other hand, in case of a foreign site, it is possible to entrust a provider authorised and registered at the Ministry of Health with the performance of this activity.

It should also be said that the subjects involved in the distribution of medicinal products – and therefore taking part to the drug traceability system – are also univocally identified. For a better monitoring of the distribution activities, the Ministry of Health attributes to each of them an identification code based on the location in the territory. These logistic sites can be authorised to manufacturing, wholesale, including direct sale, disposal and public sale of medicinal products.

Manufacturers, distributors and wholesalers are all bound to a registration into the data Bank and to transmit to it any handling of packs of medicinal products for human and veterinary use. Manufacturers, distributors and wholesalers shall also transmit to the data Bank all economic values of such handlings.

Written By: Maria Pia Felici