Like so many sectors, new technologies, software and developments in artificial intelligence (AI) and machine learning (ML), are having a profound impact on the medical device and pharmaceutical industries.
This was accelerated significantly by the COVID-19 pandemic and, while there are many benefits, this pace of development can be hard to keep track of – especially for pharmaceutical giants operating in many countries, all with their own regulatory requirements. This is also forcing regulatory bodies to constantly update guidance to ensure patient safety, and this in itself creates a raft of compliance challenges from a labelling and artwork perspective.
Should a labelling or artwork error be identified and a recall triggered, there can be significant financial and reputational consequences. For those operating within the pharmaceutical industry, this can also irreparably damage patient trust.
The Scale of the Problem
According to the US Recall Index Report, the number of medical device recalls increased in the first half of 2023, up 10.3 percent on the 447 recalls recorded during the same period in 2022. Perhaps unsurprisingly, quality issues were the most common reason for recalls, accounting for 38 events. Parts issues were the second-most common concern, linked to 27 recalls. However, software, mislabelling, and safety were third and each cited in 20 separate recall incidents.
Looking at FDA drug recalls in 2022, 166 manufacturing sites generated 912 drug recalls. So far this year, the FDA has recalled one product per month relating to mislabelling – one of the most common reasons for recall, surpassed only by undeclared ingredients and contamination.
In the UK, printing, labelling, and packaging errors have also been cited in a number of safety alerts and recalls. The Medicines and Healthcare products Regulatory Agency (MHRA) recorded seven safety messages in September of 2023, with four of these relating to missing or incorrect information, or labelling errors. Should they encounter a recall, businesses need to take decisive and fast action to get their products back out to customers and clinicians, with the correct labelling and artwork in place.
To achieve this, they need intuitive technology that has been designed to quickly update labelling and artwork.
Acting Fact
Whatever the reason for a recall, should a company identify a label that needs amending, either due to an error or change in regulation, manual methods are often slow and unintuitive. For those businesses who haven’t faced any major issues, it can be easy to simply avoid the problem, adopting an ‘if it ain’t broke, don’t fix it’ mentality to labelling and artwork management (LAM). But the complex nature of the industry, and need for full traceability and accountability, mean that businesses need to be prepared for all eventualities. It’s important to highlight that it’s not just recall events that drive the need for labelling and artwork changes. As we have already discussed, the pace of development across the industry is fuelling regulatory updates and product reformulations, two factors that also increase the number of label and artwork updates required.
