The telling difference between a packet of real and counterfeit pharmaceuticals can be as simple as the colour tone of the packaging, a change that a consumer could easily attribute to a brand update. The difference on the inside of course, is far more dangerous.

Measuring the true scale of the vast network in which such counterfeits are made, transported, and sold is difficult, given its inherently criminal nature, but we know it to be significant. In December of 2018, PharmaTimes reported on estimates of an annual €27bn in revenue lost in Europe to counterfeits and WHO estimates that a third of all medicines sold worldwide were counterfeit.

Legislators have of course set out to counter the problem, and to develop and enforce regulations that standardise practices to make products more traceable. New technologies have a big part to play in this; blockchain is likely to become ever more present in ensuring the sanctity of the supply chain for example, and packaging is steadily becoming smarter.

“Several areas of serialisation regulations have helped improve the safety of RX [medical prescription] products in several areas across the globe," explains Greg Cathcart, CEO of Excellis Health Solutions. "In the US specifically, the Drug Supply Chain Security Act Regulations have forced the adoption of standard labelling across the industry to adapt to the requirements.

"Since every unit of product is required to carry certain data requirements (serial numbers) to meet the regulations, it has required new equipment on each packaging line that is more up to date with smart technology that can be used to track & trace the product from the day it’s packaged, through the date of receipt at the dispenser."

He adds: “In the EU the regulations are similar to the US, but also have an added level of protection required. Each unit of product must carry similar data requirements (serial numbers), but each unit is also required to have a tamper evident packaging component included. Tamper evident technologies come in many forms (i.e. carton flaps that must be glued verses tucked) and provide what we describe as the first level of protection.

"Again, like in the US, these requirements have generally meant an overhaul of every single packaging line that supports these regions on a global basis. Many people don’t recognise that product consumed in the US and EU is packaging globally.” 

Packaging’s contributions to pharmaceutical safety are not necessarily reliant on developing technologies; as in the food and drink space, clear labelling has become increasingly important for the sake of both transparency and ease of use.

Smart packaging is the sector likely to best contribute to combatting counterfeiting on a large scale. Leveraging digital technologies such as blockchain in combination with physical elements such as radio-frequency identification (RFID) will help transform packaging of all types into a far more effective tool in the effort to ensure the security of products. 

Oliver Pittock, managing director of pharmaceutical packaging supplier Valley Northern, said: “Pharmaceutical packaging is at the forefront for pharmaceutical and patient safety and there should be emphasis on its importance. The Falsified Medicines Directive (FMD) now means that all pharmaceutical packaging must have safety features attached, including a unique barcode and anti-tampering device that can deter and prevent tampering.”

He continued: “Technology is changing pharmaceutical packaging for the better, by providing a number of benefits. Nowadays, it’s not always the case that we simply take medication from a box or bottle, particularly as packaging is becoming more advanced. From RFID that can connect to smartphones to set reminders and monitor medication dosages, to sensors and 2D barcodes embedded in packaging for tracking and safety purposes – technology is making pharmaceutical packaging easier to use and more secure for everyone involved.”  

Some of these technologies, such as RFID, are not exactly new but are being approached in new ways that increasingly see a more interconnected and holistic digital-conscious approach to packaging. It will be such an approach, ensuring the ‘smartness’ of packaging and its processes at every level, that helps ensure a secure future for the sector across usage cases.

Although the industry has taken notable steps to ensure pharmaceutical safety through packaging, there is still room to improve. Developments will likely stem from a two-pronged approach between regulation and technology, providing manufacturers with both the motivation and the means to ensure product security. Intelligent packaging solutions are still rapidly developing, and attention has largely been given so far to more consumer-facing applications, but the technology will continue to develop in ways that enhance security options (particularly with the advent of Industry 4.0).

On the regulatory side, measures such as the EU’s FMD ensure obligatory safety features and tougher rules and monitoring that should help guarantee compliance to the highest standards. There is always a degree of delay to be expected in the passing of legislature but aggressive and appropriately future-proofed regulation will play a key role in enforcing a high quality of protection. It will also be required to comprehensively pursue those involved in the business of counterfeiting and make sure that obligatory protections are keeping ahead of the counterfeiters.

Pittock said, “Further innovations in pharmaceutical packaging will rely on technology and active and intelligent packaging will increase. Active packaging such as inks that detect a change in temperature can prevent patients from consuming medication that hasn’t been stored correctly. Intelligent packaging is more interactive, for example, some packaging can be embedded with sensory tags that connect to a patient’s smartphone to deliver information about a pharmaceutical product.

“The FMD was a big step for the industry, but I think that security will continue to override all packaging features for the foreseeable future.”