security and traceability in the digital age

The pharmaceutical supply chain already benefits from a wide range of digital technologies. Credit: Shutterstock

Since the beginning of the pandemic, the pharmaceutical supply chain has been under scrutiny. It has never been a topic of conversation in the past, and now it is firmly on the radar of the public, and the related challenges are hardly out of the news.

In the early days of Covid-19, the main problem was drug shortages, as manufacturers faced interruptions in the supply of raw materials and factories closed around the world. Later, this affected companies that developed vaccines, which needed equipment difficult to access such as filters and bags for bioreactors. In some cases, companies lacked full visibility of their shares.

Then, as vaccination programs began, the cold chain came into focus. Despite the great efforts of all stakeholders, the scope and urgency of the introduction put pressure on the existing systems.

“The cold chain maintains medications at the right temperature during their journey so that healthcare professionals can be sure they are fit for purpose and safe to use,” says Mike Hobby, Checkit’s transformation partner in healthcare.

“Items like vaccines go through many stages, supervised by many different people, on their way from the manufacturer to the patient. You have to know that there was consistency during that time. ”

Pharmaceutical supply chains, he explains, depend on a complex set of processes, often involving a range of participants spread over a number of locations. Success depends on the right people doing the right things, in the right place and at the right time.

“Historically, it has been difficult to keep track of what is happening at each stage, due to a lack of remote monitoring and over-reliance on manual checks and paperwork that is usually isolated. This is a special concern when dealing with temperature-critical medications, such as vaccines, ”he says.

Regulatory limbo

In the United Kingdom, these types of challenges are exacerbated by Brexit. On 1 January 2021, the United Kingdom said goodbye not only to the EU, but also to the EU Counterfeit Medicines Directive (FMD).

As a legislative safeguard, the FMD ensures that medicines delivered in Europe are exactly as they seem. Each package has a bar code, which hospitals and pharmacies must scan at the point of issue. As a result, counterfeit or substandard drugs will be harder to enter the pharmaceutical supply chain.

Since the beginning of the year, end-users in the UK have been automatically disconnected from the system, raising concerns about the security of drug supply in the UK. The new bill, the Medicines and Medical Devices Act 2021, aims to fill a ‘regulatory gap’ around counterfeit medicines, but its text is controversial and progress is slow.

According to the Royal Pharmaceutical Society, this limbo condition ‘could leave the UK vulnerable to an influx of counterfeit medicines’.

Technology to help

Of course, as is often the case in times of crisis, it is possible to frame these disturbances as an opportunity. Blockchain company FarmaTrust has called on the British government to modernize the system. If this is achieved, it would put British drug safety ahead of Europe. It would even surpass the U.S., where the Drug Supply Chain Security Act is accelerating the transition to a digital supply chain.

“While we currently have an active risk of counterfeit medicines for the UK – especially given the scope of the Covid-19 immunization program – it is also an ideal time to reassess our entire drug supply chain,” said FarmaTrust CEO Raja Sharif. “With Brexit, the UK has the opportunity to implement the world’s most secure drug supply chain.”

In essence, this would mean using blockchain-based technologies to increase security and visibility. Supply chain participants could track every step along the path of the drug, including accurate details of delivery and storage conditions, and that record would be impossible to falsify.

Together with a number of industry partners, FarmaTrust is working on a pilot project to develop the UK’s first blockchain-based pharmaceutical supply chain. The consortium has been awarded £ 53 million in state money from British Research and Innovation (UKRI) and the Made Smarter initiative, with the aim of creating a blueprint for a ‘connected network of smart factories’.

“Blockchains are currently in the hype cycle,” comments Nitin Dsouza, head of the international supply chain at the global digital consulting firm Publicis Sapient. “However, as more and more companies try it out and adopt it, it has the potential to be one of the key technologies for visibility.”

How the digital supply chain could work

Although the blockchain-based system may be several years away, the pharmaceutical supply chain already benefits from a wide range of digital technologies. The idea is to enable end-to-end monitoring and planning, provide full visibility and automate what were previously manual processes.

“Technology is evolving not only to provide real-time data on the state of temperature-critical drugs, but also to encourage, direct, and record actions that people should take in response to any problematic variation,” Hobby says.

“These new tools can actually tell you how much time you have until the vaccine expires, so you lose as little as possible and build confidence in the supply chain path of any particular batch, without having to travel between places to check. ”

For example, many cold chain companies now install temperature sensors in their boxes. These sensors can be connected to telematics to provide you with real-time updates.

“These same technologies can make it possible to track individual bottles from manufacturer to patient,” says Dsouza. “On the supply side, items can be tracked by linking purchase order data, transport order data, warehouse tracking systems and telematics in transit. The data sets that are generated are huge, but the use of scalable cloud-based databases makes it easier to filter key insights. ”

Pharmaceutical companies themselves use digital tools to help plan demand, ensuring that stocks make the right amounts of stock. Amit Nastik, global head of strategy and operations and local market production at Novartis Technical Operations (NTO), says Novartis is working to simplify and digitize this process.

“We use predictive analytics and artificial intelligence to generate forecasts,” he says. “This has helped us be less sensitive to unexpected changes. We are working to build a fully interconnected supply chain using new technologies such as artificial intelligence to increase efficiency in our own operations. ”

Why go digital?

Undoubtedly, the pandemic was a learning opportunity for pharmaceutical companies and their logistics partners. Whether it’s keeping vaccines frozen or keeping counterfeit drugs away from patients, technology can play an important role even in the absence of regulations.

Hobby says digital supply chains have so many advantages that it would be surprising if they didn’t become more and more present. In addition to strengthening patient safety, you make life easier for healthcare professionals and everyone else involved in the pharmaceutical supply chain.

“You take the burden of manual monitoring off staff, who have to focus directly on patient care,” he says.

“Build a better audit trail for compliance, with accurate evidence and specific workflows for corrective actions, and enable trend analysis. You reduce the cost of lost medicine – not just the cost of the medicine itself but also the associated costs of re-ordering, longer delivery times and re-booking appointments for patients. ”

Digital supply chains could, therefore, be truly transformative for the pharmaceutical industry as a whole – and certainly one of the better things that will result from the merger of Brexit and Covid-19.

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