Pills
A white paper on the challenges around serialisation titled Product Serialisation to Advance Pharmaceutical Authentication and Patient Safety has been released by Sharp Packaging Solutions, part of healthcare services provider UDG Healthcare.
Counterfeiting and product diversion are major problems faced by the global pharmaceutical industry. In 2007, the World Health Organization estimated that drug counterfeiting accounted for 1% of sales in developed countries and over 10% in developing countries. Five years on, 2011 estimates suggest counterfeit drugs account for up to 70% of the total market in developing countries, and that even in highly controlled supply chains, 1% of drugs are counterfeit – not taking into account those drugs diverted to street sales[2].
New regulation such as track and trace serialisation will seek to eliminate the market for global counterfeit drugs. These regulations come into effect in the US in 2017 and in Europe from 2019. Analysts estimate that the impact of the new directives will increase the rate of outsourced pharma packaging from 15% to 17.5%.
The aim of the regulation is to:
• Decrease the impact of counterfeit and diverted products.
• Improve supply chain visibility and management.
• Reduce inaccurate event reporting and strengthen pharmacovigilance efforts.
• Increase patient safety and engagement.
Sharp Packaging Solutions has been engaged in the serialisation of individual unit dose pharmaceutical products for over eight years, and as such has serialised over two billion units of pharmaceutical products from their US and EU packaging facilities. Sharp currently has 25 serialisation programmes with seven of those being international. There is currently a rapidly expanding roll out programme with 16 packaging lines set up so far with imminent plans to expand further.
The white paper on serialisation was launched at the recent Pharma Packaging Labelling Summit 2015 in Zurich.
Speaking at the summit, Gaurav Banerjee, director technical services - US and EU, Sharp Packaging Solutions, commented: “The pharmaceutical industry faces complex issues in ensuring patient safety. It must test and provide safety and efficacy profiles on its prescription drugs during clinical trials and throughout the product lifecycle, maintaining strict quality control procedures in manufacturing and the safety of the product throughout distribution.
“Although the pharmaceutical industry is being mandated to embrace serialisation, the programme will have a positive impact on patient safety and supply chain security. Companies need to prepare for the upcoming directives and bear in mind the scale and cost of the task ahead.”