Tony Cordrey is Vice President of European Strategic Operations at Accord Healthcare. Having been at the forefront of the Falsified Medicines Directive (FMD) rollout, he believes we’re only just scratching the surface of what 2D matrix coding can achieve for industry and patients.
I work across operations, strategy, supply chain and environmental health and safety compliance. I’ve been in the industry for over 30 years in operations and commercial. I’m a chemist by background but an operations person at heart. I’ve been with Accord for four and a half years. We are one of the fastest growing Indian companies and have the ambition to be a top five pharmaceutical company. However, we’re clear that if we put our patients and customers first then that will enable us to become top five.
“The 2D matrix is the first time that a product brings together the manufacturer, customer and authorities and it can go so much further, especially with the potential of the Internet of Things”
Was industry prepared for FMD?
FMD is the biggest European, IT-system platform-led project. It was always going to be incredibly difficult for everyone in the EU to come together on time. There were a number of phases to be initiated for a manufacturer as well as the marketing authorisation holder for each country involved.
The first activity was purchasing equipment; Intas/Accord purchased some 70 new pieces of equipment across its operations costing millions. This stage was ‘fairly simple’ though it is challenging to integrate new equipment into an existing production line whilst minimising disruption to supply.
The second activity was purchasing servers and proprietary systems, or some developed their own. This is the first time these integrated systems have been used in the EU, and they need to be integrated from manufacturing throughout the supply chain via a central European hub to end users. National systems also had to be built, providing integrated end-to-end systems to carry manufacturing data through to pharmacists and wholesalers.
Obviously, the systems and processes play a huge part in FMD throughout the supply chain from manufacturing into national authorities; it’s been challenging. I believe there was an underestimation of the level of effort required to get it going. It has required the right people with the right training and knowledge in order to get everything prepared. There were a lot of regulations to be interpreted and put into place across the supply chain covering many countries, languages and national authorities.
The reality of the medical supply chain was more complicated than expected. There are many inter-transactional activities across many stakeholders ensuring medicines reach patients. It was paramount that the solution was not at the detriment of patient access to medicines, whilst at the same time ensuring rigour in the supply of bona fide medicines.
It was a huge undertaking, but currently, the number of people uploading data to the EU system is very low, and that’s a challenge. There are also a huge number of errors or false positives every day. There are taskforces working through the errors, but it’s a real challenge. However, it’s necessary in order to be able to identify the true counterfeit products.
Do you have any advice for those who may be struggling with FMD?
If anyone is struggling with FMD, or new entrants to the market, the equipment aspect is fairly easy, but you must understand the systems and get them right. In the early days, the master data is incredibly important. There’s a huge range of master data to bring together with lots of acronyms which need to work in the EU system.
I’d encourage people to get an expert in serialisation on board. Issues will arise in uploading data and if you don’t have the specific expertise and understanding of master data, it makes it a lot harder.
Also, if the master data is wrong the entire batch can be returned, meaning you need a good quality management system along with master data for the packs and the system. These are critical. Set-up should be undertaken incrementally to make it easier to spot errors.
What role can technology play?
We are only at the edge of what we are doing with technology; we’re following legislation to add the 2D matrix codes from manufacturing to pharmacist, but it doesn’t stop there. The 2D matrix code offers a world of opportunities and it’s currently just one-directional. There’s so much more that can be done. Given the investment by industry, there’s more to be gained than just verification.
What does the future hold for falsified medicines?
We really need stability in the FMD system before moving forward. However, once this has been achieved, the possibilities are incredible. We’ve had schools visit our operations and the first thing the children do when they see a 2D matrix is get out their phones to scan and read it. They see it as a gateway which opens up a wealth of opportunities.
It could link to the manufacturer’s website for product data sheets and patient information leaflets (PIL), patients could access pharmacovigilance information, report side effects, or have links to who to contact if they have concerns. There are so many possibilities. This could eventually save the need for printed PILs, saving paper and making the information accessible. We have been here before with e-PILs discussions but now industry and patient are in contact via digital technology.
This is the first opportunity for patients to take control of their medication. They could verify the product is legitimate and this can feed back into the system. The GP could then know that the patient has received their medication and has been informed of the product information and side effects. There’s even potential to remind patients to take their medication or when to go for repeat prescriptions, it can be fully integrated.
The 2D matrix is the first time that a product brings together the manufacturer, customer and authorities and it can go so much further, especially with the potential of the Internet of Things. As future generations come forward, this can only grow.
Currently, it’s just for counterfeiting, but as you can see, it has the potential to do so much more.
The only caveat I have is that technology is outpacing regulation and it will need to catch up with the potential that technology brings. Right now, it’s an opportunity and I look forward to the potential realities.