Sharp partners with clients to ensure traceability

Counterfeiting and product diversion are major problems faced by the global pharmaceutical industry. In 2007, the World Health Organization estimated that counterfeit medicines accounted for 1% of sales in developed countries and over 10% in developing countries1. Four years on, 2011 estimates suggest counterfeit medicines can range between 1% and 70% of the total market in developing countries, and that even in highly controlled supply chains, 1% of medicines are counterfeit – not taking into account those medicines diverted to street sales2.

New regulations such as ‘track and trace’ serialisation will seek to eliminate the market for global counterfeit medicines. These regulations come into effect in the US in 2017 and in Europe from 2019. Industry observers estimate that the impact of the new regulations will increase the rate of outsourced pharmaceutical packaging from 15% to 17.5% over the coming two to three years3. The aims of the regulations are to:

  • increase patient safety and engagement;
  • decrease the impact of counterfeit and diverted products;
  • improve supply chain visibility and management; and
  • reduce inaccurate event reporting and strengthen pharmacovigilance efforts.

Sharp Packaging Solutions has been engaged in the serialisation of individual unit dose pharmaceutical products for over eight years, and has serialised over two billion units of pharmaceutical products from our US and EU packaging facilities in partnership with leading technology suppliers. Sharp has 25 serialisation projects with its clients, several of which are international and operate across multiple markets. There is currently a rapidly expanding serialisation roll-out with 16 packaging lines enabled to date. Sharp has invested significantly to ensure sufficient technology, expertise and capacity is available to support all customer requests for serialisation when the emerging regulations are implemented. Sharp’s serialisation capability has increased from three project specific lines in 2010 to having the capability across each commercial packaging facility to support up to five levels of aggregation. Sharp has also enhanced its engineering and technical teams to produce and implement around four serialisation modules per quarter.

1 World Health Organization., accessed September 24, 2013.
2 Pitts P. Counterfeit drugs and China new
3 Jefferies UDG Healthcare company note, October 2014.

The pharmaceutical industry faces complex issues in ensuring patient safety. It must test and provide safety and efficacy profiles on its prescription medicines during clinical trials and throughout the product lifecycle, maintaining strict quality control procedures in manufacturing and the safety of the product throughout distribution. Over the last few years, we have been partnering with our clients and our technology partners to prepare for the upcoming regulations, ensuring that we have the best experts in the industry, best in practice technology and processes to be on-hand to be the best partner for our clients.

Rick Seibert

Senior Vice President Global Innovation and Technology Services, Sharp Packaging Solutions