Recognising the benefit of product data in helping protect patient health and safety – the result of regulatory serialisation requirements in developed economies – key stakeholders, including hospitals, pharmacies and healthcare providers, are putting pressure on pharmaceutical manufacturers to go a step further.
Stricter serialisation practices – requiring identification down to the individual dose of a pharmaceutical product – could help to mitigate unsafe medication practices and medication errors and offer improved patient protection.
However, as Ian Chapman, Domino Printing Sciences, explains, this new dimension in pharmaceutical serialisation brings new considerations for product coding and marking.
Mitigating medication errors
Multiple factors are in play when it comes to medication errors – from preparation to patient monitoring; inefficient in-house systems; or human factors such as fatigue, poor environmental conditions, or staff shortages. A simple mistake can have potentially devastating effects, resulting in severe patient harm, disability and even death.
Stricter serialisation measures – with individual identification down to the specific dose – can play a crucial role in helping to mitigate some of the risks associated with medication errors in pharmacies and healthcare providers and ensure that the right patient gets the right dose of the right medication at the right time.
Adding more granular data to strips and blister packs of medicines, for example, can allow for better control within hospitals, care homes, and other healthcare facilities to improve medicine distribution.
Scanning serialised 2D codes can allow for automatic electronic validation of medicines to ensure patients receive the correct medicine and dose. This level of detail decreases dispensing errors and can improve inventory management and stock control.
Individual dose identification
Today, products are typically produced with a 2D code that contains product, dose, batch code, and expiry date information on secondary boxes and packs.
The next level will require solutions for coding each product dose – which could include vials, ampules, and individual blister pockets containing a tablet.
While the benefits of individual dose serialisation are obvious, the industry needs the buy-in of pharmacies, doctors, hospitals, and other healthcare providers to drive change.
To prepare for a future where individual dose identification is the norm, pharmaceutical manufacturers may need to update their current coding and marking capabilities.
Although pharmaceutical manufacturers are now well-versed in how to print serialised 2D codes correctly to ensure that they can be effectively scanned, individual dose coding comes with additional complexities.
When coding products in-line, product handling or the ‘presentation of the product’ to the coding device is fundamental to achieving high-quality codes and will become more crucial for manufacturers looking to explore individual dose identification.
Manufacturers that attempt to code products in-line without effective product handling will be subject to production line variations that can affect final code quality, including
- Product position: small variations in the position of products on a production line may result in codes being applied in the wrong area or missing or incomplete codes
- Product distance from the printer: positioning too close or too far from the coding device can result in blurry or unreadable codes
- Product angle: a slight rotation in product positioning, even by just a few degrees, can result in deformed codes
- Line speed: minimal speed fluctuations will affect the quality of the code, leading to squeezed or stretched codes
- Conveyor vibrations: at high speeds, vibrations can affect code quality leading to low-quality, blurred, or wavy codes
- Challenging product geometry: certain packaging types can be challenging for a standard coding set-up.
At best, a poor quality 2D code resulting from inadequate product handling will cause rejections, rework, and defective stock. The repercussions will be even more severe if an unreadable 2D code leaves the factory unnoticed.
Pharmaceutical brands may face financial penalties such as fines, loss of business, product recalls, and potential legal implications. The introduction of individual dose identification increases this risk and complexity.
Data requirements
While the introduction of individual dose identification significantly enhances traceability and can aid in error reduction, there are challenges in the amount of data that now needs to be generated, tracked, and managed for both the manufacturer and at all stages along the supply chain.
All modern printing technology will "print" the images delivered to it and can cope with thousands, millions, and billions of data changes; however, this needs to be handled, stored, and managed to ensure traceability remains unimpeded.
For example, imagine a blister pack containing seven tablets and a production run of one million individual packs. Typically, the manufacturer must create, store, and print one million codes to comply with the serialisation requirements of one code per pack.
Tracking down to the individual tablet increases the data requirement to seven million codes. It is likely that this data already exists, but it doesn’t need to be stored until the point at which it is printed. In this instance, serialised coding at the tablet level increases the data storage requirements by six million pieces of data.
Therefore, the step to individual dose identification comes with a burden of data volume and storage requirements that manufacturers will need to consider when implementing any new solution.
In addition, the increase in data storage will influence overall energy use, and as such, total carbon footprint, and will there necessitate action from manufacturers to ensure alignment with other sustainability commitments.
Globally, the legislative requirements of serialisation are well known, and manufacturers are the key to implementing a solution.
Cost is no longer a barrier, with more advanced labelling and serialisation systems available at lower price points, though equally, implementation of any new technology will come with challenges, and manufacturers will need to strike the right balance, and work with the right providers, to manage competing objectives.
Ultimately, with patient safety a key driver, demand for this data and pressure to provide it can only increase – so the time to prepare is now.
Prepare today for tomorrow’s new dimension
When it comes to individual dose identification, it is not a matter of if manufacturers will have to comply; the key question is when.
Demand for greater levels of traceability and accountability in the pharmaceutical industry is only set to increase. Manufacturers will be well placed to ensure that their coding and marking capabilities are equipped to enable accurate and reliable identification of each dose and handle the increased data demands.
By doing so, manufacturers can enhance patient safety, reduce the risk of counterfeiting, and ensure compliance with the latest regulatory standards.
By partnering with a reputable provider who can ensure that lines are equipped with the latest solutions, manufacturers can ensure they are prepared for future serialisation requirements.
