Tracked, traced and trusted

Implementation of automation technology that address Serialisation requirements for the authentication of drugs can also provide the foundation for improved production, supply chain and QA efficiencies ­– offsetting the costs, argues Dean Chespy, Life Sciences development manager, Siemens Industry Automation

The failure of any pharmaceutical manufacturing business to demonstrate that it is doing all it reasonably can to secure and authenticate its products could fatally damage its brand and reputation. Businesses cannot risk a situation where lives are at stake and they have failed to implement measures that would support the kind of ‘track and trace’ product strategies regulatory authorities around the world are beginning to insist upon.

The World Health Organisation (WHO) estimates that up to 1% of medicines available in developed countries are likely to be counterfeit and the worldwide trade in counterfeit drugs currently accounts for 5% of all drugs sold. While in previous times it was thought the problem was purely limited to developing countries, there is now clear evidence that it has become a more commonplace issue in so-called developed economies as well.

The explosion in the popularity of internet-based ‘pharmacies’ is exposing patients – who are attracted by competitive product prices found on the web – to potential inherent risks as such a distribution channel cannot offer the product traceability and quality reassurance found via traditional dispensing channels. The WHO estimates that potentially 50% of medicines available from internet sites which conceal their physical address may be counterfeit. In addition, some counterfeit medicines discovered in the UK have been found to contain a reduced amount of the active pharmaceutical ingredient which creates concerns both in terms of safety, as well as value for money for the consumer using such means to access medicines.