Ian Lemon, Essentra, looks at the issues the pharmaceutiucal sector faces with counterfeiting and where the future of packaging is heading
The real thing: According to Ian Lemon, Essentra, tamper evident features provide a physical indication to the consumer regarding the integrity of a pack
The World Health Organisation estimates that up to 15% of all pharmaceutical drugs globally are counterfeited. This translates to around 1% of drugs in Europe and the USA with the issue is particularly severe in the developing world. As the supply chains for pharmaceuticals are now global and increasingly complex, the opportunity for illegal activity will continue to grow. This must be countered with a focus on monitoring and maintaining the integrity of the supply chain by paying more attention to detail and having proper protocols in place.
In 2011, the European Parliament and Council of the European Union formally recognised the public health threat posed by counterfeit pharmaceutical products and agreed upon a definition for a ‘falsified medicinal product’ as well as actions that should be put into place to combat the threat. Today, the implications of the directive are more broadly known, as is the 2018 deadline for implementation. The directive has served an important purpose in highlighting the growing issue of counterfeiting in pharmaceuticals as well as some solutions including serialisation and tamper evident packaging.
Serialisation
Serialisation is the system of tracking, tracing and verifying pharmaceutical products, with the goal of ensuring patients are taking reliable medicine. A unique identification can reveal the transactional history of the drug, from supply chain to patient distribution. Serialisation can take many different visual forms, for example as a linear barcode, 2D barcode or a combination of numbers. Technologies for more advanced solutions are being developed, but the format of the unique code differs from country to country.
The advantages of drug serialisation are widely known. Serialisation can confirm the integrity of the medicine. A serial code reveals key information about the drug, such as its name, quantity, expiration date and can allow capture of key events in the process from manufacture to patient. In some cases, each serial number connects to a larger network of numbers which identify the medication within a bulk container, case or carton. Authentication of pharmaceutical drugs is of critical importance, as counterfeiting poses a high level of risk to the industry and to the consumer.
Tamper evidence
Tamper evident features provide a clear physical indication to the consumer regarding the integrity of an individual pack. As the final line of defence against counterfeiters, it provides an important layer of protection and allows consumers to make a judgement about the authenticity of their pharmaceutical product.
Indeed, while serialisation provides unit-level track and trace, counterfeiters could easily collect used packaging (such as cartons) and refill these with fake product, reclosing the original packaging and passing the product off as genuine. Tamper evidence solutions help to prevent this by leaving a visible mark on the original packaging, so the end user knows it has been opened.
Tamper evidence solutions are available in many forms, such as labels, overwraps, and glued cartons, each having their own benefits and considerations for pharmaceutical manufacturers.
In the case of labels, these are available with varying levels of security. For example, high-adhesion labels with a tear feature ensure that if attempts are made to remove the whole label, the carton below will be visibly compromised. Void release labels ensure that when the label is removed, aspects of the label are left behind permanently on the packaging. Hidden holograms work in much the same way as void release but provide additional security verification through being bespoke.
Only by layering attributes will the industry be able to deliver enhanced protection. That is why companies such as packaging specialist Essentra have developed technologies to integrate security within product packaging supporting industry needs from serialisation to tamper evident features.