Pharmaceutical serialisation: what’s coming down the line? 

Bart Vansteenkiste highlights the patient safety measures that may be coming down the line and the steps manufacturers should take to prepare

The complexity within pharmaceutical supply chains is exceptional, with ingredients and medicines often crossing the borders of multiple countries before reaching the end consumer. Driven by patient health and safety, serialisation and track and trace requirements are now standard for pharmaceutical products worldwide. Legislation includes the EU’s Falsified Medicine Directive (EU FMD) and the US Drug Supply Chain Security Act (DSCSA), which both necessitate serialisation through every step of the supply chain, as well as government reporting for prescription pharmaceutical products

Beyond counterfeit protection 

Hospitals, pharmacies, and healthcare providers are now realising the benefit of data in helping to protect patient safety. Consequently, pharmaceutical manufacturers are under pressure to provide greater levels of granular information on pharmaceutical products than current legislation requires. 

When it comes to pharmaceutical products, serialisation can extend far beyond protecting patients from the risk of counterfeits. It can facilitate increased patient health and safety in pharmacies, hospitals, and community healthcare settings. With more sophisticated serialisation of prescription and non-prescription pharmaceuticals, healthcare staff can ensure that a medicine is not counterfeit and that the right patient gets the right dose, of the right medication, at the right time. 

Including a 2D code – containing product, dose, batch code, and expiry date information – on individual strips or blister packs, or even going so far as coding each pocket containing a tablet, can help to reduce the number of cases where patients unintentionally receive the wrong dose of the right medicine, the wrong medicine, or, in some cases, no medicine at all. 

In some countries, pharmacists are legally required to only sell the exact number of tablets a patient needs, meaning they need to open medicine packs. In these cases, if machine-readable codes are only present on the carton pack, all forms of verification and authentication may disappear from the strips or blister packs in the separation process. 

Adding more granular data to strips and blister packs of medicines can allow for better inventory control within hospitals, care homes, and other healthcare facilities to improve medicine distribution. Scanning 2D codes can allow for automatic electronic validation of medicines to ensure that patients are given the correct medicine and dose. This level of detail decreases dispensing errors and can improve inventory management and stock control by allowing medications to be tracked down to the individual dose level. 

In-line digital printing 

The demand for more granular data will necessitate an upgrade to current manufacturing equipment to enable the printing of variable information on blister foil packaging. Until recently, most pharmaceutical manufacturers would buy blister foils pre-printed with product names, dosage information, and branding, and use a basic in-line printing or embossing system to add the batch code and expiry date to the blister in human-readable text. 

Adopting an in-line digital printing solution provides the necessary flexibility and can allow manufacturers to respond much more quickly to changes in print requirements. One of the most significant benefits of digital printing solutions for in-line pharma is that many are equipped to handle single-dose serialisation, where unique 2D codes and serial numbers are printed on each pocket in a strip or blister pack. 

In addition, whereas in the past, manufacturers would typically have had to wait several days or even weeks for pre-printed foils to arrive in the event of a change in product design; a new legal requirement; or need for a different language, with in-line digital printing, the need for pre-printed foils is negated. Manufacturers can switch from one design to the other in a fraction of the time, while the technology also makes it economically viable to run much smaller batches, e.g. as little as 50 blisters or less.

By investing in a digital printing solution today, manufacturers can future-proof their production lines and prepare for future serialisation requirements. 

Waste and cost reduction

When investing in a digital in-line printing solution, the potential savings often outweigh the price difference between a narrow printhead that is only suitable for printing variable information (i.e., 2D code, batch code, and expiry date) and a wider printhead that can also print larger graphics, including artwork. Wide web digital printing allows manufacturers to purchase blank foils and carry out coding in-house, reducing stock requirements and inventory space. In addition, as blank foils are less expensive than pre-printed, even when accounting for the cost of ink, this allows for significant cost savings. 

This new approach can also significantly decrease waste, helping pharmaceutical manufacturers reduce their environmental impact. Manufacturers typically order 10-20% extra when purchasing pre-printed foil to allow for unforeseen issues or wastage from set-up and product changeovers. There is no excess waste with blank foils, as manufacturers can reuse any foil for subsequent print runs. 

Much development has been done in the last couple of years to increase the availability of suitable inks for pharmaceutical coding. UV curable inks are a standard application for metallic foil printing, and there are now many Swiss-List-approved, CMR-free variants available. There are also many water-based options suitable for paper-based packaging that deliver as much contrast as the classic UV drying inks – these are suitable for use in flexible papers, which are growing in popularity as blister pack seals. 

Down the line

The future of pharmaceutical serialisation is anything but clear; however, patient safety and counterfeit protection are – and will remain – a top priority in the sector. Future regulations will likely expand upon current requirements and force pharmaceutical manufacturers to provide more granular product data.  

Even without the prospect of a new regulation looming, pharmaceutical manufacturers are already under pressure from key industry stakeholders to provide additional product data to protect patients’ safety and reduce the risk of errors. 

By investing in digital printing solutions today, manufacturers can ensure they are prepared for any future serialisation requirements that may be coming down the line while also benefitting from cost and waste savings involved with printing the exact amount of packaging they need. 

Bart Vansteenkiste is Global Life Sciences Sector Manager at Domino Printing Sciences.