Packaging
serious threat to public health, and this is something governments should take very seriously.”
Fake news
This is a view reflected by global pharmaceutical giant Novartis, which is taking steps to counter the counterfeiting problem.
Daniel Fritz, a supply chain technology architect at the company, spoke about the challenge, and how Novartis, along with several other major players, is coming together to find solutions. “With the advent of novel medicines, it was unfortunately predictable that fake medicines would become an issue for patients, health authorities and governments across the globe,” he says. “However, even prior to Covid-19, the issue with fake medicines and the devastating impact that this has on the quality of care that patients receive, and the detrimental impact – mental and financial – that this has on patients’ families, was and still is a major issue across many markets.”
Creating easily identifiable layers of authenticity within packaging could hold the key to fighting back against medicrime of this nature. Packaging includes what consumers see, open and read (often in the form of small paper leaflets) before taking the medicine inside. It is this process that confirms to them whether the product is authentic, and many may not even contemplate that what they have just acquired is fake.
Novartis is working closely with other pharmaceutical companies and public partners as part of the PharmaLedger consortium. Sponsored by the Innovative Medicines Initiative (IMI) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) under the Horizon 2020 programme, it seeks to build a trusted patient- centric platform where the patient is empowered to manage and retrieve trusted information pertaining to their healthcare needs.
In total there are 29 partners, including 12 major pharma companies, with the aim to accelerate blockchain solution adoption in the industry for the benefit of patients.
Fritz takes us back to the beginning with perhaps the most critical component of pharma packaging – the leaflet. “In order to achieve this ambitious goal, it was necessary to select a starting point and a use case in order to show what was possible.” That starting point was the ‘simple’ leaflet that is included in every pack of medicine. This ‘simple’ leaflet is actually not so simple, as it turns out. It contains valuable information for the patient on how to take the medicine, potential side effects – public information that is available from many sources, some legitimate (health authority websites for example) and, unfortunately, some illegitimate. “The answer to this,” reassures Fritz, “is the barcode and
World Pharmaceutical Frontiers /
www.worldpharmaceuticals.net 61 Focus on vaccines
As well as exacerbating the problem of counterfeit medicine, the Covid-19 pandemic triggered a huge and rapid vaccination roll-out that forced packaging companies to respond in kind.
The scale and speed of distribution is unprecedented, and the variety of vaccines produced created a complex spectrum of transport, storage and distribution requirements, which at the extreme end involves temperatures as low as −80°. Packaging companies responded equally fast to these changing dynamics. For example, many companies created tailor-made corrugated trays with inserts and buffers to keep vials secure during transport and handling. There is also a role for packaging to play in terms of counterfeiting and tampering – it must be easy to use for medical staff, who rely on anti-counterfeit features to help identify potentially fake or tampered vaccines.
the anti-counterfeiting technologies – overt and covert – that are built into most pharmaceutical products.” The concept of electronic leaflets is not new, and there are solutions whereby a barcode on the packaging of pharma products provides the leaflet upon scanning. However, that system is still open to abuse. The majority of existing solutions can and unfortunately are often used to essentially legitimise fake medicines – the barcode on a fake pack of medicine directs the user to a legitimate source of information, thereby giving the patient the impression that the pack of medicine is genuine. Data, according to Fritz, is the answer. Novartis and the PharmaLedger team have been working on a solution that uses the available data in the barcode to perform checks on the authenticity of the pack it is attached to. Thanks to serialisation techniques, packs of medicine are given a unique serial number, often presented on packaging in the form of a QR-style code.
“So, what makes this barcode so special?” Fritz asks. “Actually, the barcode itself is not special – what is special is the data that it contains. The barcode has the GTIN [the global trade item number] – the product, basically – the batch number, the expiry date and also a serial number.
It is hoped that blockchain-enabled pharmaceuticals will allow for easier detection of erroneous medicines.
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