As part of a recent serialisation technology day, Domino stressed how important the threat posed by falsified medicines is to the pharmaceutical supply chain. The seminar focused on the requirements for preparing pharmaceutical manufacturers for serialisation when the Falsified Medicines Directive comes into force at the beginning of 2019 and attracted a large audience from across the UK. Craig Stobie, head of the Domino Global Life Sciences team, highlighted similar legislation being enacted around the world as a response to the continued spread of counterfeit and falsified medicines.
“In Europe, at least 30 million units of falsified medicines have been seized at borders in the last five years alone. An estimated €10.5 billion is spent on counterfeit medicines across Europe every year, with six in every ten online purchases turning out to be fake,” Stobie said.
“Statistics such as these demonstrate the risk posed by this trade to patient safety globally: in some cases it can be fatal, as many counterfeits contain poor quality ingredients, are the wrong doses or simply just don’t work,” Stobie said. “As with the FMD across Europe, countries around the world have put in place or are planning similar legislation to prevent the illegal trade. This includes new legislation in the USA, Brazil, Argentina, Saudi Arabia, India, China, South Korea and Turkey.”
Stobie said common themes of emerging legislation include the need for manufacturers to provide a unique product identity at item level, the addition of one machine readable code per pack and that legislation predominantly covers all prescription medicines, as well as high risk over the counter medications.
“With the FMD set to come into force in three years, pharmaceutical manufacturers will gain greater protection in ensuring stock is accounted for,” Stobie added. “With item level serialisation, all pack data must be represented with a machine readable code, information must have good and resilient contrast against the background and a minimum of four mandatory data elements including a unique carton number. Where applicable, the pack will need a national reimbursement number as well.”
Summing up the key points, Stobie added there is no off the shelf, universal technology to address serialisation for manufacturers and that different packages work best depending on each business’ circumstances. To help manufacturers, Domino has written a series of best practice documents to assist customers in deploying a cost effective and robust solution. Customers can access the documents online or by emailing falsifiedmedicines@domino-uk.com .