TraceLink sets out vision for connected healthcare

The last few years has seen efforts to secure the pharmaceutical supply chain crystallize around the use of unique serial numbers on packs to allow them to be tracked through the supply chain and authenticated before being dispensed to patients.

More than 80 per cent of the medicines sold around the world need to comply with that requirement by 2019 and - assuming those deadlines in the US, EU and elsewhere are met - the industry is on the brink of having greater visibility over its supply chains than ever before.

Pharma serialization specialist TraceLink now wants to look beyond complying with those regulations and explore the ways serialized packs can play a broader role in healthcare.

The company's chief executive Shabbir Dahod told SecuringIndustry.com during the company's Nexus17 event in Barcelona that the ambition is to "take information and move it end-to-end across the supply chain to drive better patient outcomes."

"This has been our ambition right from the beginning," he said, noting that over the years all of TraceLink's systems have been constructed with that interconnectedness in mind. "But of course you need to have serialized product flowing through the supply chain before you can add the next layer of capabilities and value."

Now, the time is right, as serialization is already starting to deliver benefits in securing the supply chain and protecting products, via integrated networks that can provide track-and-trace of products between thousands of partners – pharma companies, contract manufacturers and packers, wholesalers, repackagers, hospitals, pharmacies etc. TraceLink has 250,000 entities in its network – including more than 1,400 contract manufacturing organizations – with millions of serialized products commissioned every month.

So now the company feels the time is right to take the next step - using the unique identifiers on packs to enhance communication and information flow between all the players in medicines supply, right from the manufacturer to the patient.

To that end, TraceLink is developing a new set of applications – under the Information Network Services (INS) banner – that will sit on top of the TraceLink network and provide a point of contact between all the players in the medicines supply chain.

The first of these is a mobile and web-based application for EU pharmacies - the Pharmacy Compliance and Digital Information Platform (PCDIP) – that aims to help them comply with incoming regulations on the verification and decommissioning of medicines that are due to come into effect in February 2019. It will go further, however, providing a real-time dashboard that TraceLink says will provide "business insights on medicine scans, expiry dates, dispensation trends, product inventory and more."

Pharmacists can also 'opt in' to a service within the app – on a per-product basis - that will open up a communication channel with pharmaceutical manufacturers. The intention is to give them the opportunity to receive additional product-related information - details about indications, usage, best practices for product administration, and potential warnings and precautions for example – as they dispense a medicine to patients.

Recognising that hospital and pharmacy systems have a wide range of technical prowess – some already have practice management software systems in place while others will have more limited capabilities - TraceLink has developed the app both as a stand-alone system and as an API – in other words allowing it to be integrated and interfaced with existing platforms.

Other new applications coming down the pipeline within the INS family will tackle things such as product availability – to help eradicate shortages – as well as verification of product and provision of information at the patient level, real-time recalls, and secure distribution of high-value products.

Dahod thinks this extension of the capabilities of the serialized network will start to mature in the next 12 to 18 months, and the time is right to lay its ideas out in front of the industry so as to start collaborating on its roll-out.

He stressed that the intention is for the pharmacist to remain as the gatekeeper of the provision of information to patients, sitting at the centre of the process and preserving – but potentially enhancing – the pharmacist-patient relationship. The pharmacist would also retain all control over the data generated within the platform.

For now the focus is on Europe, but the intention is very much to develop the concept for other markets around the world that are moving towards serialization, including the US, with modifications of the platform to take into account variations in local regulations.

"We've always had the 'end-to-end' mission, so we will provide … the capability to scan product and have serialized inventory at the pharmacy level in the US as well, as well as other countries – such as India and Brazil, etc - as laws and regulations come in," he said. The PCDIP for EU FMD requirements is expected to be available by the first quarter of 2018.

"There's a real opportunity here for us to drive real-time information-sharing for patient outcomes," said Dahod. The billions of dollars being spent on [on serialization] on a global basis is just the beginning. The value that we will generate over the next five, 10 or 20 years is going to be tremendous."