Stay safe, stay connected: A brief history of track and trace and what the future holds
In this article, Eric Tjoa, CEO and founder at Tjoapack, outlines a brief history of track and trace and explores the future for serialisation, including the opportunities that technology can bring to the sector and most importantly, patient safety.
The tracking and tracing of medicines to improve the visibility of drugs throughout the pharmaceutical supply chain is not a new concept. In fact, the idea of serialisation has been discussed for over 15 years. However, what is changing is our understanding of technology and our mindset around the possibilities it can bring to the industry.
When Tjoapack started printing barcodes on single drug units around 28 years ago, it was too early for many people to understand the value of this kind of technology in the supply chain. Today, with the introduction of varying track and trace regulations across the globe, the need to develop a safe and connected pharmaceutical supply chain is coming to the fore.
In the beginning: a brief history
While companies have been discussing the need to identify and verify medicines to protect patient safety for some time, the pharmaceutical industry has been slow to adopt new technologies.
In 1999, following a report by the US institute of Medicine, President Bill Clinton placed patient safety (including preventing errors at the point of dispensing medicines) on the agenda of federal government and continued to lobby for changes after his presidency.
In 2003, the US Food and Drug Administration (FDA) mandated barcoding on unit doses and in the same year, the World Health Organisation (WHO) published a report recognising the scale of the counterfeit medicine challenge stating that 10% of medication worldwide was counterfeit.
A step change took place in serialisation around 2005 and a number of countries began to set deadlines for implementation. However, after making some strides towards securing the supply chain, the challenge became less of a priority during the financial crisis in 2008.
As the global economy has improved, slowly the momentum has shifted. Turkey introduced serialisation requirements in 2010 and other markets such as China, South Korea and India have regulations in place. With the EU Falsified Medicines Directive (FMD) coming into effect in February 2019 and the US introducing legislation in November 2017, as part of the Drug Supply Chain Security Act (DSCSA), it’s expected that more than 75% of global medicines will be covered by some form of track and trace regulations by 2019.
While the EU FMD is limited to the verification of medicines at the dispensing point and, therefore, does not allow for the tracing of drug products throughout the whole pharmaceutical supply chain, it is a positive step towards establishing a more secure system.
Look to the future
The counterfeiting of medicines is an enormous problem and with increasing access to drugs via the internet and an extremely complex global marketplace, the situation is not getting easier. The mobility of people and drug products will only increase, while buyer behaviour and the way we access medicines is likely to evolve.
An ageing population is also placing new pressures on global healthcare systems, requiring more efficiency throughout the supply chain to meet demand and reduce costs.
Patient empowerment is another interesting trend that will affect the way that medicines are delivered. Patients of the future are likely to demand more control over their medications, requiring the ability to self-verify their origin and genuineness using mobile technology. Mobile applications can also in the short-term assist medical personnel, allowing them to get a faster and better response for their patients.
While we are beginning to witness the use of artificial intelligence in the automotive industry in the form of self-driving cars, we must explore the use of this technology in improving the pharmaceutical supply chain. To operate safely, self-driving cars must assess a lot of data to make the right decision. Similarly, serialisation involves large volumes of data that must be securely stored and exchanged. With the advancement of cloud-based applications, data storage is no longer such a big challenge as it was in the past and won’t limit innovation in the future.
Our ability to exchange and process data will also become more advanced. With the right technology, it has become entirely possible to digitally connect with all your partners in the supply chain through one simple click. This could also be applied to the end user. Soon, it will be entirely possible to imagine a hospital of the future where doctors sit behind screens and diagnose patients based on data from various remote locations.
Standardisation should also be an aim for the future of serialisation and track and trace systems. Global standardisation initiatives often require political involvement, however in the case of satellite navigation systems and mobile networks, the benefits of breaking down global boundaries have been realised. The healthcare sector needs to push towards global standardisation as collaboration is the key to accelerating developments.
Final thought
There is still some way to go until global alignment is achieved. However, the fact the EU has finally taken note of the problem of counterfeiting and made this issue a priority is a positive. The FMD means there is now much more clarity on the responsibility of stakeholders throughout the supply chain in eliminating the problem of falsified medicines.
Being able to imagine how the pharmaceutical supply chain can be transformed and improved using technology requires a particular mindset. Today, a new generation that has grown up with smartphones is helping to drive a mindset shift and an acceptance that technology can bring major benefits to not only the pharmaceutical manufacturing process, but critically, the safety of patients across the world.
Other sectors such as the automotive industry have a much more transparent network supply chain, making use of artificial intelligence, the internet of things (IoT) and mobile applications. It’s expected that these trends will also impact the future of the pharmaceutical supply chain, helping to create a safer and more connected global network.
Eric Tjoa will be presenting at NEXUS 17, an annual forum, hosted by TraceLink, taking place on 7 and 8 June in Barcelona.