New technologies will be crucial for the future success of the pharmaceutical industry and pivotal for manufacturers to maintain profitability, reputation and consumer safety while keeping up with growing demand and public need, says Duncan Moir, Product Manager, Epicor Software
The UK’s pharmaceutical trade represents an advancing and highly dynamic area of business. With an annual turnover of £70 billion, it is one of the largest developing industries in the global market.
As a whole, the sector is responsible for maintaining the health of the nation — within an ever-evolving world — and this responsibility comes with potential risks that can lead to disastrous consequences if systems are not appropriately maintained.
Large-scale drug recalls, for instance, can be potentially life-threatening for those involved — as well as being hugely costly and damaging for businesses. According to officials, there were approximately 37 UK drug recalls in 2019, all with different potential health risks and financial implications.
One of these included the recall of Neupro and Vimpat, used to treat Parkinson’s and epilepsy, after they had been incorrectly stored and therefore rendered ineffective.
With advances to pharmaceuticals being made every day, alongside rapid innovations in medical technologies, there is a growing need for traceability and visibility through the entire pharmaceutical supply chain — from production and processing through to distribution.
New and exciting technologies, such as artificial intelligence (AI), are already being used to enhance the drug creation process — making it cheaper and more efficient to produce medicines on a large scale. However, with these developments comes an urgent need for manufacturers and businesses to maintain a high level of traceability to reduce the risk of errors and, thus, to life.
With life-threatening and long-term conditions continuing to rise at a rapid rate — and better detection techniques uncovering more diseases that we previously didn’t know we had — the health sector is under increasing pressure to develop new treatments every day.
In fact, recent research reveals that UK heart disease fatalities are now on the rise and one person is being diagnosed with type 2 diabetes every 3 minutes in England and Wales.
As issues such as obesity and unhealthy lifestyles continue to spiral out of control, obesity related hospital admissions in England have also risen by 15% compared with the previous year — putting even more demand on the sector to innovate.
Increased funding for research from governments and charities, along with the need to quickly respond to new viruses, will only fuel this pressure further — putting the onus on pharmaceutical companies to release effective drugs to the market as quickly as possible.
Despite this growing demand for new treatments, the FDA clinical drug approval process is currently completed through a five-step plan, with medicines taking anything from 10–30 years to finalise and costing an average of £2 billion to produce.
Given the significant investment and lead time associated with pharmaceutical development, production companies simply cannot afford to get this process wrong.
The only way to ensure this is by placing greater importance on traceability and visibility throughout the entire development and distribution process. Key stages when traceability is key include the sourcing of materials, the point when materials enter production and the various machines used in production — right through to specific batches produced and which batches go to which customers.
Although the standards of traceability remain higher in pharmaceutical development than most other sectors, owing to the highly regulated nature of the industry, there is an increasing need to trace movements outside the production areas and include movements in storage. For example, to observe if cross-contamination could have occurred during storage and to check and maintain the temperature and humidity of that storage location.
Much like food manufacturers, drug companies also have to control allergens. But there is a reason why pharmaceutical developers are one of the more monitored and regulated sectors of today’s manufacturing industry. After all, products designed to kill off bacteria and infections are automatically going to carry more risk to health if handled incorrectly.
Businesses who ignore the importance of visibility are therefore risking more than just a product recall and a partially damaged reputation — all impacting the bottom line. In the worst-case scenario, there is even the potential risk of death. Given the importance of a secure and monitored production line, there must be a push for greater visibility to limit the impact of these incidents.
Even once a finished drug has been produced and clinically tested, there are still multiple pitfalls to consider — which is when different technologies can work together to ensure maximum visibility and traceability.
By implementing software such as enterprise resource planning (ERP), businesses can fully track the usage and movement of all ingredients, work-in-progress and finished products while checking storage conditions at each stage of the process.
Rules can also be imposed on the storage conditions required for each ingredient, intermediate and finished product throughout the process, thus ensuring the quality of the finished product. The software also enables constant and reliable visibility of all drug storage spaces.
In combination with ERP, new technologies such as blockchain and the Internet of Things (IoT) can be used to extend the traceability to include the distribution chain.
These technologies allow sensors to detect where the product is at any point in time.
They can also monitor the conditions onboard trucks and other transportation units, such as temperature and humidity. Blockchain can then provide a secure mechanism to store this information.
Because of an ERP system’s ability to integrate with multiple platforms and filter relevant data, blockchain can essentially be used as a plug-in tool that helps to expand current analytical possibilities and gives users a more comprehensive view of what’s happening.
Businesses are then able to monitor the conditions, from the point of distribution through to the delivery to the customer, providing a much better level of visibility across all operations.