Why is item-level serialisation needed?
The WHO estimates that up to 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 serialisation is a way to reclaim territory from increasingly sophisticated counterfeit criminals.
Is it compulsory?
Not currently, but it soon will be.
Counterfeit medications are a global problem. Governments across Asia, Europe, South America and North America are drafting legislation on the use of item-level serialisation to fight back. Building on the 2011 Falsified Medicines Directive, the deadline for legislative compliance for prescription medicines in the EU member states is expected soon.
Who’s affected and what are the challenges?
The move towards item-level serialisation means the pharmaceutical industry faces a race against time to adapt operationally. Everyone is affected: manufacturers, producers, packers, importers, wholesalers and distributors.
Challenge #1: Getting the right equipment
There’s a lot of printing technology out there. How do you know which is right for your business? And which technologies have the ability to cope with item-level serialisation? Codes must be applied at speed with high readability. Then there are packaging substrates and labelling designs to consider.
The proposed model of serialisation is a combination of a 2D data matrix code and human readable text. For these codes to be verified fast, print quality is crucial. This, coupled with the demand for production line speed, makes laser and thermal ink jet (TIJ) 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 the tip of iceberg. 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.
Challenge #3: How do you handle all the data?
Item-level serialisation brings with it the need to maintain a data log on each physical asset. That’s a huge data challenge, both in terms of storage and cohesive access to the data from production through to the pharmacy. And if a pack is rejected or otherwise removed from the supply chain, how will it be removed from the database? How will the rework of false rejects be logged?
There is no precedent. Careful, cohesive planning is a must.
Challenge #4: Production line speed
The impact to production line speed in transitioning to item-level serialisation should not be underestimated. Early adopters have reported serialisation 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 minimise 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.
Be proactive. The time to act is now.
In the face of such challenges, many manufacturers have adopted a cautious, you-first way of thinking. That’s a dangerous approach. Although the finer points of the legislation are yet to be confirmed, there is enough detail to begin moving towards item-level serialisation. And there are three important benefits of being proactive.
- You troubleshoot potential problems early and become compliant ahead of schedule, minimising stress and disruption further down the line.
- You enhance your reputation in the industry.
- You become an authority that can help to inform industry policy and legislation.
The move to item-level serialisation is a big challenge. But acting now could save an even bigger challenge down the line.
You can read more on how to combat the pharmaceutical serialisation challenge in our free white paper.