Devendra Mishra Executive Director of Bio Supply Management Alliance interviews Be4ward Principal Consultant Grant Courtney on the topic of traceability capabilities within the global Covid-19 vaccine supply chains.
Q. How has the lack of visibility/ traceability in the end-to-end COVID-19 vaccine supply chain been of major detriment?
A. I would suggest that the lack of end-to-end traceability has not been of major detriment to vaccine supply rather that many of the issues being encountered can be attributed to other factors. Very few countries in the world have currently implemented traceability systems across their end-to-end supply chain. Turkey was the first and perhaps the most comprehensive system currently in operation. The system tracks the product from the point of manufacture through to the point of dispense and is used to prevent falsified products, reimbursement fraud, product diversion and promote the safer use of drugs. To achieve this, GS1 Standards have been implemented to allow the identification of items such as a pack, case or pallet and also for locations. Traceability events are then captured as the medicines move through the supply chain.
Visibility in the Turkish system is achieved through the use of a central traceability system which was financed by the Turkish Medicines and Medical Devices Agency (TİTCK), which is affiliated to the Turkish Ministry of Health. This project took four years to achieve, starting in 2008 and completed in 2012. So clearly the establishment of traceability systems takes many years, relies on the establishment of legislation and requires significant investment and effort across all the stakeholders required to use the system. In Turkey there are over 42,000 stakeholders connected to the system, including 408 manufacturers, 592 wholesalers and over 25,000 pharmacies.
Another significant example of implementation of serialisation is the European Medicines Verification System (EMVS) which was set up in response to the EU Falsified Medicines Directive. As the name suggests, this is not a track and trace type system such as the one described in Turkey. The primary purpose of the EMVS is to verify every pack prior to dispense. This system does not provide complete visibility of the supply chain as not all product movements are tracked through the system. The fact that relatively few countries currently operate full track and trace traceability systems, tells us that end-to-end traceability is not a pre-requisite for a well-run and controlled supply chain, although clearly it helps and has additional benefits.
Many of the challenges for the distribution of a COVID-19 vaccine are going to be the same as any other product, such as the need for common identification of an item, standard barcodes, accurate product master data and supply chain partners who are able to share data and transact through common processes. It is more likely to be issues in these areas that present challenges to the distribution and management of a COVID-19 vaccine, rather than the lack of traceability per se.
It could be argued that it is the introduction of common standards, processes and interoperable systems that drives many of the benefits when establishing a traceability system, as these are all needed for traceability to function and are evident in highly efficient supply chains.
Utilising common barcodes at all levels of the packaging from the vial up to the pallet would allow items to be scanned and the data captured for Logistic and Clinical purposes. Product Master is made available to all stakeholders so that systems can be populated. Transitions based on global protocols and standards ensures there is more interoperability of processes and systems. These are all factors that enable any supply chain to operate with Global Standards very much the DNA of any highly efficient and effective supply chain.
Q. How can serialisation of drugs and vaccines enable the required integrity in the manufacture and distribution of drugs?
A. Although serialisation and traceability are not the primary factors in operating efficient supply chains, there are benefits which come with their implementation. Traceability through the vaccine supply chain using track and trace offers benefits by providing full product visibility from manufacture to patient’s arm. Knowing where inventory is at each stage of the supply chain makes for a safe and efficient supply chain. The benefits go further than just manufacture and distribution, all the way to administration of the drug and pharmacovigilance.
By giving each product a unique identifier, we know it is a legitimate vaccine, we know the vaccine type and how many doses are contained in a vial. We also know the location of each vial at all times. This full visibility aids redistribution, recall and the integrity of supply chain before we even consider the big benefits of preventing product falsification and diversion.
As we collect more data on these vaccines, it could be that we are able to extend shelf life. Traceability and digital data store to vial level allows us to update information held without having to recall or waste product. Similarly, there are benefits relating to electronic patient information. Much of this product is going out in common packaging across all countries, in a single language on the packaging. Barcodes can be used to scan and access leaflets in different languages.
Due to the acceleration of manufacture with these vaccines, extra vigilance is required relating to, for example, side effects. Robust, reliable product data is essential here with product code and batch code linked to patient records for pharmacovigilance purposes.
Q. In the emerging global situation of the disparity between demand and supply of COVID-19 vaccines, falsified products may appear in the marketplace. What is the solution?
A. Unfortunately, we have already seen criminals profiting from the pandemic. Initially this was PPE items and some therapeutics, but there are now reports of criminal gangs gearing up to supply fake vaccines. In February 2021 authorities in China arrested over 80 people and 3,000 doses of fake COVID-19 vaccines were confiscated. It is understood that the group had been profiting from making and supplying the fake vaccines since September 2020 and that it is likely these were destined for export to countries in Africa. We have the conditions for the perfect storm, high value vaccines with high demand and low supply. This is a recipe for falsified products which will be distributed through both physical and online channels.
There is no single solution to solving falsified crime. If there were, we wouldn’t be facing the issue. What’s needed is a suite of capabilities and solutions in place to minimise the risk and take into account the national environment and needs. Patients want this vaccine in their arm. It’s the key to reopening lives and economies. It will afford the vaccinated greater freedoms, and therefore a strong demand exists. Consequently, some patients will buy it illegitimately, whether just queue jumping or due to concerns over a lack of supply.
One route for falsified product to enter the marketplace is via the internet. I’ve written an article relating specifically to cybercriminal activity around these vaccines, whereby efforts to fight this crime are being made by organisations such as EAASM and ASOP, to raise awareness with consumers. This is where the high media profile of these vaccines is of benefit. It’s highly publicised that there is no extra out there, so unless your vaccine is secured via legitimate channels, it’s fake. Also, policing the sellers and monitoring cross border movements helps the effort.
As well as tackling the illegitimate supply chain, we must also secure our legitimate supply chain. This highly valuable product is hugely vulnerable to theft and hijacking, leading to the dangerous situation of spoiled batches in circulation. This is a particular issue in low-middle income countries. We need to put systems in place with monitoring efforts on the legitimate supply chain to ensure its security.
Q. With the desire to foster international travel, what is a Healthcare Passport for travellers?
A. A Healthcare Passport for the vaccinated would extend beyond just travel, it could mean individuals being able to work, attend a conference, or visit a care home. If we are granted more freedom or have more opportunities offered to us by being vaccinated, then the evidence we carry becomes very valuable and therefore a target for forgery. Methods of proving vaccination in a failsafe way is a huge challenge. For example, who confirms you’ve been vaccinated? Staff at the centres are busy vaccinating and caring, so who keeps the records? We will need to create a link to the record of administration and who the patient is, relying on robust identification at the point of vaccination. All this requires further levels of administration and staffing.
These ‘passports’ are going to be really important if we’re going to get some industries safely back up and running, such as travel, leisure and entertainment industries. But how will we make them as secure as current travel passports or online banking for instance?
Q. How can IoT enhance the potential business value of serialisation?
A. Web enabling packs, where every pack can be treated as a unique thing with a unique identifier brings about huge benefits. This means you can leverage track and trace, but also can provide additional information about each specific thing by scanning to get to additional pack content. This could be for example a leaflet in a different language, or the new expiry date. You can create use cases such as product verification to link to patient records.
Q. How would you quantify the economic value of an investment in serialisation?
A. The two main benefits of patient safety and supply chain efficiencies are hard to put an economic value on. Patient safety, the safe product correctly administered, means less stress on the healthcare systems. Unsafe product could result in legal action, people being removed from the workplace, damaged healthcare systems, reduced staffing and additional treatments, all at huge cost to society. Improving the efficiencies of your supply chain presents great economic value too. With COVID-19, the global economic cost has been extreme. A stronger, more visible supply chain for the vaccines will help us reopen societies and begin our recovery.