24 Apr Technological advances could mean a real solution to the problem of counterfeit drugs
Technological advances could mean a real solution to the problem of counterfeit drugs, with a potential answer lying right here in the UK.
With prescription and over the counter medicines being part of every day life for millions of people in this country alone, as well as huge numbers in the USA where 40% of all worldwide annual prescribed drugs sales take place, it is an issue which touches the lives of everyone and something which one coroner in Northern Ireland has called an “escalating crisis”.
The United States also has a growing problem with counterfeit drugs. In 2012, faked steroids killed 11 people near Boston and injured another 100. Another case showed medicine pertaining to be cancer medicine Avastin actually contained no active ingredients. The vials were sourced in Turkey, shipped to Switzerland, then Denmark, finally to the UK from where they were exported to wholesalers in the US.
But developments in technology can mean that pharmaceutical companies can use Distributed Ledger Technology to ensure the validity of their supply chains, protecting not only their products and their brands, but also lives.
The global pharmaceuticals market was worth $934.8 billion in 2017 and expected to reach $1170 billion in 2021, growing at 5.8% according to market research. There is an incentive for companies to ensure that their products are not copied but given the customer base is everyone in the world, there is also a strong demand for counterfeit drugs.
But research, including some at Portland State University, have shown the huge potential benefit which using DLT could bring.
Matthew Kendall, Technical Director of GSM explained how the process could work.
“DLT, or Blockchain as it is sometimes called, can store transactional records of each step of a manufacturing process, creating the ledger – or chain – of information. Only authorised users with access to the database can add to the stored information and of course the beauty of this technology is that you can’t just delete previous entries, only add, with any changes made resulting in notifications sent to all users involved in that particular ledger.
“This protocol allows sellers to track and verify products without relying on a centralised database which is vulnerable to attack by hackers and organised crime groups.”
“Counterfeit drugs are targeted at the most vulnerable: those living in poverty in developing countries, without access to proper medical care or choice in the providers of their medicines, and those who are sick and in need.
“If technology has the potential to stop unnecessary deaths as well as stopping an illegal trade which could be funding vile, nefarious activities across the globe, then it should be doing so. At GSM we have a desire to leave behind a legacy which is not just financial; our emphasis is on sustainability and using technology for good.
“Pharmaceutical companies don’t just have to be part of a tick box culture complying with mandatory regulations, such as the well intentioned EU regulation on Falsified Medicines. Instead of just using the new two step safety feature on packaging of most prescription and some over-the-counter medicine including a two dimensional barcode and anti tampering device, they can embrace the latest technology and be industry trail blazers.”
GSM have developed a solution which uses digital tags that include a product’s name, serial number, expiry date and any other information a business – or their end user – may wish to include such as trade marks, allergy information, other products made, contraindications and even push notifications for repeat prescriptions. This could disrupt and disable illegal supply chains and is not just possible for big production numbers but smaller numbers, although it is scalable.
As with other GSM solutions, the technology can be linked to readers or smart phones, allowing real time checks along the supply chain, including pharmacies, GP surgeries and other medical professionals dispensing drugs directly, and even consumers.
“Many people in the UK are on some kind of regular medication and for a company, dispenser or prescriber to have a direct link via a smart phone app could provide valuable information for all users as well as providing the peace of mind that a medicine is legitimate,” added Kendall. “Someone suffering from an illness should not have to worry that their medication is what it says it is and we believe this solution can provide that reassurance, particularly for those who already have enough worries.”
Current requirements for manufacturers include a requirement to upload the information contained in the unique identifier for each individual medicine onto a central EU repository which is part of an end-to-end medicines verification system introduced by the Regulation. Depending on the source of the medicine, wholesalers will also need to scan medicines at different points in the supply chain to verify their authenticity. Pharmacies and hospitals will then scan each medicine at the end of the supply chain and check them out before dispensing them to patients.
The EU says these safety features will ‘guarantee medicine authenticity’ for the benefit of patients and business and will strengthen the security of the medicine supply chain.
Around the rest of the world, most deadlines on single line verification have passed, but some still have years more to run before new laws come into place.