Drug safety between pharmacovigilance and traceability
Recent events regarding the vaccine currently used against the Covid-19 infection has highlighted the importance of the monitoring activities of adverse reactions and of the drug traceability carried out by the Italian Medicine Agency (AIFA) and the Italian Ministry of Health, respectively.
The former – a public body ensuring access to drugs as well as their safe use, circulating information that promotes knowledge and awareness relating to medicines – carries out this function of control through the mechanisms of pharmacovigilance. This provides for the reporting of adverse reactions in relation to therapies, their inclusion in the National Pharmacovigilance Network (RNF) and in the European EudraVigilance System, the examination of pharmacovigilance signals, the assessment of periodic safety update reports (PSUR) as well as the implementation of an additional monitoring of drugs whose risk/safety profile needs to be continuously under control.
On the other hand, traceability is a capillary tool allowing the monitoring of drugs all over the territory, in the distribution channel up to the final user, in order to ensure the availability of safe and controlled products, to prevent falsified and counterfeited drugs to enter the distribution chain, and to allow prompt measures when required to protect public health.
In the case of Covid vaccines, thanks to accurate recording of some product data (name, batch number, date of administration etc.) in the vaccination sheet of each patient, AIFA and the Ministry and all the concerned authorities were able to track the batch received by patients and take all necessary steps.
However, all drugs can be tracked thanks to the presence of the antifraud sticker on the pack; this is an adhesive label including, partly in full and in barcodes, the product data allowing the absolute and specific tracking of the whole life cycle of the single pack put on the market, from when it leaves the secondary manufacturing site, where the sticker is applied, to when it reaches the final purchaser.
Along with information regarding the medicine, in fact, the antifraud sticker is characterized by a progressive number identifying univocally each pack, whose “history” inside the distribution system can therefore be put together.
The sticker is an exclusive Italian requirement, born out of the need to fight against any form of illegal practice in the sphere of drug distribution: now the European pharmaceutical legislation – monitored by EMA – has also introduced a unique bi-dimensional barcode that, just like the Italian sticker, will make easier to track drug packs in the EU market. For Italy, a time extension was granted until 2025, just because of the presence of the antifraud sticker.
The American FDA also provides for the supply of traceability data on drugs between the partners of a transaction; these also include a national drug code made of a numeric string including a product code as well as package code.
The possibility to track a drug during its route from the manufacturer to the consumer is therefore a crucial aspect in the controls carried out by authorities on medicinal products, and contributes to the availability of safe and effective products and to the possibility of rapid and targeted measures.
Written by: Maria Pia Felici
Foto di Michal Jarmoluk da Pixabay
