By Luca Proietto, Consultant at Hardis Group.
The fight against counterfeiting, quality control and drug identification and authentication are long-standing concerns of the pharmaceutical industry. Although traceability has long been operational in this sector, digital technology now makes it possible to go even further with efforts to secure the supply chain and even to provide patients with additional services.
The pharmaceutical sector at the forefront of item traceability
Traceability in the pharmaceutical industry is essential for patient safety. To this end, the industry has used Datamatrix product identification for many years. The advantage of this technology is its ability to encode a large amount of data (batch number, expiry date and, more recently, serial number) in a small size and to be printed in different sizes, depending on the number of characters, the technology and the material on which it is printed.
More recently, the Datamatrix solution has made it possible to integrate drug serialization, the sector’s latest requirement when it comes to traceability in Europe. One of the aims of the European Directive 2011/62/EU on falsified medicinal products is to combat the massive influx of counterfeit drugs into Europe, putting patients’ health and lives at risk. In practice, this means that every member of the supply chain checks the unique identification number of medicinal products. Each box is scanned and the serial number is retrieved from the Datamatrix. Laboratories and pharmacies have different obligations. In Europe, every stakeholder must submit the Datamatrix serial numbers to the National Medicine Verification Organization (NMVO), in charge of serialization governance in each country, using an official application.
At a logistical level, only a Datamatrix scan is allowed (as opposed to a manual entry). Non-conformity is indicated if there is no Datamatrix or it cannot be read. Although the impact on logistical productivity is significant, this is vital to ensure product safety and authenticity. Traceability is now the cornerstone of consumer trust in the health system and the products used within the system.
Digital safety, a driving force for drug safety
Behind the traceability of every box of pharmaceutical products, the focus is on ensuring the safety of the entire associated digital chain. Of course, this begins with strict access management: accounts with temporary privileges (execution of critical applications), traceability of individual connections, automatic disconnections, etc.
The audit trail (logbook) makes it possible to reconstruct events regarding the creation, modification and deletion of an electronic record (what, who, when and why), so that every link in the logistics chain can be sure of the integrity of the data at its disposal.
In this era of an increasingly digitized drug chain, electronic signatures have become essential. Although a simple signature is currently authorized, more advanced techniques, such as the use of biometrics, are likely to become increasingly pressing issues in the future.
In any case, every user action must include at least one electronic signature within the relevant systems.
Digitization and automation: towards tomorrow’s pharmacy
While patient safety and the assurance of receiving certified medicines are paramount, it must not be forgotten that patients are customers, particularly in pharmacies. Consequently, they expect high levels of service and short lead times and are not understanding about product shortages.
Some products are sensitive and have specific requirements in terms of their storage. At the same time, competition from supermarkets and e-commerce sites is pushing traditional pharmacies to reinvent themselves by offering their customers click & collect and curbside pick-up services, for example. To do so, these pharmacies must deal with the challenges of more sophisticated logistical management to ensure the smooth flow of goods, whatever their nature.
To this end, an increasing number of pharmacists are choosing to use automated devices or robots. Although these devices are still expensive, they offer immediate benefits in terms of provision, storage and stock management. Using this type of equipment also makes it possible to spend more time focusing on patients, their symptoms and their medical prescriptions. Once these devices are rolled out, there is an average increase in sales of personal care products (15-30%) and non-prescription medicines (10-40%).
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