Security and Brand Identity in Pharma Blisters

An Opportunity with Printed Cold Form Foil

When patients recognise the brand of the drug being prescribed, and are confident that it is genuine, they are much more likely to take the medicines correctly, improving their effectiveness, and therefore the patients’ health outcome.

Packaging is the key carrier of information to the patient, and numerous measures have been taken to add anti- counterfeit and brand identity features, but so far with very limited success, as the burgeoning global trade in fake drugs, and poor patient adherence data will testify.

This article discusses a simple option for those drugs packed in Cold Form Foil, which could be implemented in short order for minimal cost.

A Brief History of Cold Form Foil

Cold Form foil (CFF), also known as alu-alu, was introduced in the 1970s in Europe, and has since become the preferred blister base for the most sensitive oral dose products for the majority of Pharmaceutical companies in Europe, the Americas and more recently Asia-Pacific.

The original CFF specification remains almost unchanged since its invention, with a single structure still accounting for well over 90% of global usage. With worldwide production now approaching 60,000 tonnes and $500M annually, CFF is used in around 20% of the world’s pharmaceutical blister-packed solid doses. Only a handful of CFF manufacturers are capable of delivering the consistency and quality required for global regulated markets, with the top 10 manufacturers sharing over 80% of the worldwide demand, and fewer than 5 of them that sell significantly outside of their own region.

Until around 2005, two major European producers were sharing around 90% of the European demand, and over 80% of the global total. As the Healthcare industries of Asia began to flourish at this time, first Korean foil manufacturers developed their own CFF, then Indian and Chinese converters followed suit. This coincided with a rapid growth in demand for Pharmaceutical packaging in China and India.

The manufacture of CFF is technically challenging, with quality and consistency of raw materials, production equipment and processes, and skilled engineers and operators all required to deliver a product that runs consistently well on blister packing lines.

In the past decade, the demand pull in Asia has led to a significant improvement in local equipment, labour skills and raw materials – foils, films, adhesives and lacquers – that has led to a number of Asian suppliers now producing

a consistent quality and performance that rivals the global leaders. Asia now represents over half of the global usage of CFF, with demand at around 30,000 tonnes.

Brand Security and Differentiation

The rapid growth in Asia has led to an increasing need for Pharmaceutical companies to protect their products against counterfeiters, with packaging as a key tool to fight against these illegal traders.

Due to its easier implementation, the secondary carton has so far been the preferred choice for enhancing security, such as tamper-evident seals, and overt and covert printed features. However, this is barely a sticking plaster on an industry wound estimated at $20-30B, which kills at least 200,000 people each year. The secondary pack only provides minimum protection, as it is still too easy to place a counterfeit blister into a genuine carton, as well as many drugs in Asia being sold by the pharmacist without a carton. Anti-counterfeit features on primary blister foils represent little more than 3% of a global market of close to $1.5B.

Recent developments in printed electronics, digital watermarks, Near Field Communication, mass customised QR codes, etc. are bringing down the unit cost of sophisticated anti-counterfeit featurs, as well as the effort of implementation, making the introduction by Pharmaceutical companies more attractive, as well as allowing the blister pack to be digitally read whilst still in the carton. As these technologies vie for their place as the solution of the future, it is somewhat surprising that a more simple, existing technology has yet to find popularity outside India.

Printed Cold Form Foil

CFF is almost entirely used in its standard specification, showing the silver-coloured aluminium on both the PVC and oPA sides of the blister. However, coloured CFF has long been available, with pigment being added to the layers between films and foil being relatively simple and cheap to produce. Similarly, there have been several examples of CFF with a print design applied in US and Europe, but only on rare occasions.

Across Asia, and in particular in India, the use of coloured and printed CFF is much more common, representing as much as 20% of the overall demand in India. Pharmaceutical companies there have realised that due to the low number of qualified producers of CFF, a print feature here provides an effective security feature, as well as an immediate brand recognition for patients and healthcare providers alike.

Material and technology improvements in the past 10 years have long allayed any technical concerns about migration or delamination, and printed and coloured CFF is now commonplace in India as a low-cost feature to enhance brand identity and security.

It is surprising, therefore, that 98% of CFF in Europe and the Americas is uncoloured, with printed CFF almost unknown. With most of the Pharmaceutical companies trying to identify ways of reducing cost, enhancing security and patient adherence, as well as differentiating their brands, the usage of this low-tech, cost-effective solution seems like an opportunity for the taking.

The benefits demonstrated by India customers are simple. Firstly, there is an immediate brand recognition by doctors, nurses, pharmacists and patients, which gives an enhanced confidence in the efficacy of the drug. Secondly, the fact that few manufacturers can produce printed CFF in a good quality automatically creates a level of security that counterfeiters cannot imitate.

Conclusion

The leading Pharmaceutical companies appear to be focusing on emerging technologies to gain broad acceptance as the solution for brand identity and security, with most seemingly focusing on the lid foil as the carrier of the information. This is perhaps unsurprising, as lid foil is used on 100% of blisters, whether the base is shared between PVC, PVC/PVdC, Aclar, PP or CFF.

However, the most sensitive, and therefore valuable oral dose medicines are commonly packed in CFF, and the off-the-shelf, cost-effective solution of printed CFF has so far been overlooked. As pressure grows on Pharmaceutical companies to act on the threat of counterfeit drugs, as well as demonstrating the effectiveness of their products, it would seem to be worth exploring this more low-tech but readily-available option.