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Centralised DataMatrix reading for drug authenticity verification

European Statement

Selection, Procurement and Distribution

Author(s)

Leonor Romero, Paloma Lozano, Veronica Canales, Vanesa Dechado, Marta Puebla, Ricardo Villarubia, Isamar Gomez, Estefanía Ramírez, Juan Rodríguez, Belén Soto

Why was it done?

According to Directive 2011/62/EU, one of the measures is the inclusion in the secondary packaging of the drug of a Unique Identifier that allows the recognition of a unitary case at any point in the supply chain until it is dispensed to the patient. Another is the development of a European repository that allows the traceability of medicinal products for human use within the European market. In Spain, in accordance with Article 84.1 of Royal Decree 717/2019 of 5 December 2009, the SNSFarma Node was established as an instrument for technological integration and information exchange with the national repository known as the SEVeM.

What was done?

The logistics company of our hospital aggregates several codes corresponding to the Datamatrix of the individual containers in an electronic file, in order to send the reading automatically to Spanish Medicines Verification System (SEVeM).

How was it done?

The shipment of the drugs and the electronic file will be linked by the Seria Shipping Container Code (SSCC), which will univocally guarantee traceability between the two. The Pharmacy Service staff receive the delivery notes by reading the barcode without the need to scan the Datamatrix of each container.
Since the implementation of this project between July 2023 to September 2023, a total of 61 delivery notes have been registered under the code aggregation system with 27 suppliers involved. The number of packages read was 2151.

What has been achieved?

This project ensures the automatic sending of readings to SEVeM and to facilitate the reception of delivery notes at the Pharmacy Services by barcode reading.
This has allowed pharmacy staff to save time in receiving delivery notes, to improve traceability of batches and expiry dates of medicines, to improve stock control thanks to the confirmation of quantities received and to verify the medicines in accordance with European regulations to fight medicine falsifications and ensure that medicines are safe and that the trade in medicines is rigorously controlled.

What next?

A limitation is the existence of suppliers that are not involved in this project since their delivery is not done through the logistics company. In these cases, the datamatrix reading must be performed on each container individually.

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