Building on the 2011 Falsified Medicines Directive, new legislation is pushing the pharmaceutical industry towards item-level serialisation. The change in legislation is intended to improve patient safety and tackle the proliferation of counterfeit pharmaceuticals. Estimates from the WHO suggest that up to 15% of the world’s medicines are counterfeit. This poses a serious risk to patient safety while jeopardising faith in the pharmaceutical industry.
There are also regulations such as the Drug Quality and Security Act (DQSA) and the Unique Device Identification (UDI) rule which requires all medical devices to be labelled with human and machine-readable identifiers through distribution and use. Both the DQSA and UDI present more compliance challenges for the pharmaceutical industry.
Big data, big challenge
It’s useful to think of every pharmaceutical item as having two parts: a physical asset and a data asset. The association between the two must remain linked from the moment identity is assigned to the moment medication reaches the patient - and beyond.
How do you store a data log for every packet of medication in a single city, let alone the whole of the EU? How do you make sure every stakeholder in every supply chain can update the relevant data log at the relevant time? How do you create a unified system that everyone from packers to chemists can use quickly and easily? The challenge is huge. But if you ask EFPIA, the perfect data framework already exists.
Cohesion over chaos: introducing GS1 standards
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has voiced its support for the adoption of GS1 standards to conquer the item-level serialisation challenge. It’s a proven framework that has been used successfully worldwide for many years for product identification. Here’s a quick breakdown.
With the GS1 framework, every party in the supply chain is given a unique global identification number (GLN), while every product that enters the supply chain is given a unique global trade item number (GTIN). <![if !supportLineBreakNewLine]> <![endif]>
- GLN - global location number (for supply chain parties)
- GTIN - global trade item number (applied to each individual supply chain product)
As well as a unique tracking code, GTINs are encoded with extended data such as lot number and product expiry date. GTIN and GLN data is shared electronically through a global data synchronisation network (GDSN). As products pass through the supply chain, they are scanned by each stakeholder and both GTIN and GLN information is updated automatically.
It maintains a chain of custody as each product moves from one stakeholder to another and provides a global standard for product identification and traceability. Order and inventory processes are instantly improved. And integration with serial shipping container codes (SSCCs) means the system can handle the hierarchical association of pallets, lots and individual units.
So how does the coding work?
GTIN data is applied via a 2D data matrix. As yet there is no confirmation that the GS1 standard will be the enforced data framework for item-level serialisation. But if you are a manufacturer, now is the time to begin considering your data matrix application capabilities.
It goes without saying that these matrices must be applied at speed to avoid production line delays. But there are other considerations too. The matrix must endure the lifespan of the product to preserve data integrity. And while speed is important, it must be balanced with the need for the matrix to be smudge-proof when using ink-based applications. Contrast and clarity must also be considered.
What technology is available?
To meet UDI and DQSA requirements, our F220i fiber Laser offers flexibility: printing permanent, high-quality codes on metals, plastics and even certain films. It can also product unlimited lines of text and graphics, ideal for 2D data matrix codes.
Data matrix patterns can be applied at speed through thermal transfer, inkjet and laser solutions. Finding the right application depends on a number of factors including throughput, substrate selection and the legacy technology on your production line. But all things being equal, we would recommend laser technology on the basis of speed, clarity and ease of integration into existing production lines.