What do you mean legislative change?
The short answer: There is no longer any doubt about whether or not item-level serialization will become a legislative requirement in the pharmaceutical industry. It’s happening.
The long answer: Building on the 2011 EU Falsified Medicines Directive, the European Commission hinted at a legislative move towards item-level serialization in the pharmaceutical industry last year. This was confirmed with the August 2015 draft release of the EU Delegated Act on Safety Features. The act has now been formally adopted (as of 2nd October 2015) and the legislation is expected to be published in early 2016.
Why is item-level serialization needed?
The WHO estimates that 15% of the world’s medicines are counterfeit. These counterfeit medicines can have dire consequences: risks to patient safety, loss of brand reputation and lost faith in the pharmaceutical industry. Item-level serialization is a way to reclaim territory from increasingly sophisticated counterfeit criminals. It will protect patients from the dangers of counterfeit medicines better than ever before.
What does the legislation mean?
Think of item-level serialization as a way of giving each bottle or packet of medication its own unique identity - a machine-readable code that can be traced at every stage of the supply chain from producer to patient. A unique identifier carried in a 2D data matrix must be printed on each and every pack. The legislation affects prescription medication only.
If you supply Europe with pharmaceutical items you must adapt your packaging and establish the systems, processes and master data to be in full compliance with the new legislation. Your authorisation to sell your products in the European market depends on it.
When’s the deadline?
The deadline to reach compliance is tabled for early 2019. It’s a race against time for the pharmaceutical industry to adapt operationally. (We discuss the challenges in more detail below.) All EU countries as well as Iceland, Norway, Switzerland and Liechtenstein will be answerable to the new legislation. The only exceptions are Belgium, Italy and Greece. These countries already have pre-existing safety features in place and the EC has extended their compliance timeline by six years.
Are you ready for the challenge?
It’s not as simple as updating your production line coding and marking equipment. The challenge of moving to item-level serialization is seismic - and has the potential to reverberate from the production line through to every corner of the business: logistics, distribution, planning, throughput, P&L and downtime.
It’s a tough challenge. But the bigger picture is one of increased efficiency. Item-level serialization will reduce inventory losses and dramatically improve the rate of returns, recalls and chargebacks. Technology will improve to accommodate the new legislative measures too. Already there have been new developments in multi-substrate inks for TIJ printers, which offer fast drying times and are clarity-optimized to minimize the numbers of false rejects produced by machine vision systems.
Here’s a little guidance on some of the strategic challenges that lie ahead.
Challenge #1: Getting the right equipment
The unique identifier proposed by the Delegated Act for packaging is a 2D bar code carrying a serial number, product code, batch number and expiry date - and for some specific EU member states an additional national reimbursement number. In a nutshell: you need to find a way to apply variable 2D matrices to your packaging.
There’s a lot of printing technology out there. How do you know which is right for your business? And which technologies are best suited to item-level serialization? Lightfast, permanent codes must be applied at speed with high readability. Then there are packaging substrates and labelling designs to consider.
Print quality and print speed is crucial for production line efficiency. This makes laser, thermal ink jet (TIJ) and thermal transfer overprinting (TTO) systems a good choice. Both can hit the requirements of existing and proposed traceability schemes.
Challenge #2: Implementing and integrating equipment
Choosing the right equipment is just the start. You also need to know how to integrate it with your existing processes and legacy technology. Your engineers may be unprepared for this. Setting aside a budget for staff training is crucial to avoid production line delays and downtime.
Challenge #3: Production line speed
The impact to production line speed in transitioning to item-level serialization should not be underestimated. Early adopters have reported serialization at 300 units per minute as comfortable; 450 as achievable but not fully robust. 500 per minute is a major technical challenge. Reject rates can be high too - around the 10% mark - in the initial stages of adoption. That puts strain on your false rejects process not to mention rejects bins, which, once full, will halt the production line.
You can minimize the disruption to your output by factoring in time for testing and pre-emptive maintenance before you begin implementing the new technologies. As a manufacturer you must also make sure that your staff are confident in dealing with issues that are not currently in their remit. Again, investment in training is crucial.
Challenge #4: How do you handle all the data?
Item-level serialization brings with it the need to maintain a data log on each physical asset. That’s a huge challenge, both in terms of data storage and data access. And if a pack is rejected or otherwise removed, how is it removed from the database? How will the rework of false rejects be logged?
Think of every packet or bottle of medication 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. Moreover the symmetry between the data and the physical asset must be open to interrogation for the lifespan of the product and beyond. This data will be available across the EU via a central data repository.
The responsibility of data reporting, data management and record-keeping falls on the Marketing Authorization Holders. Any item that is recalled, withdrawn, stolen or provided as free samples must have its status changed by parallel distributors, repackagers and brand owners as necessary.
Think about how many individual packets of medication you process each year. Your system needs to manage a data file for each and every one of them. We are talking about huge amounts of data here, with salient knock-on effects beyond the installation of new equipment - such as the need for increased IT investment, increased staff investment and stakeholder engagement.
Challenge #5: Hierarchical association
The move to individual package labelling does not remove the need to track batches and pallets, which still need to be verified at the point of sale and dispensing. This brings into question another challenge: hierarchical association - how the data for each pack in a bundle, each bundle in a case and each case in a pallet can be retrieved with a single scan. Establishing these hierarchical associations enables any party authorized to handle the product to interrogate precisely which items the batch contains.
Now is the time to act...
The new legislation represents a sea change for the pharmaceutical industry, forcing manufacturers to reinvent their processes on the journey to compliance. As you might expect, manufacturers across Europe are at wildly differing stages of adoption. Some are pilot testing their production lines, others are still at the research stage.
Yet a proactive approach is likely to bring rewards. Most notably it gives you more time to troubleshoot potential problems early and become compliant ahead of schedule, minimizing stress and operational disruption further down the line. Yes, the move to item-level serialization is a big challenge. But acting now could save an even bigger challenge down the line.