Smart pharma

The pharmaceuticals sector is one of the most vibrant users of innovative packaging technologies. Brands and their partners are leveraging convenient, easy-to-use and appealing packaging in order to deliver better patient care, optimise brand loyalty and meet their legislative responsibilities. Dave Howell speaks with industry players including Matt Whitt, head of packaging and life-cycle management at GlaxoSmithKline, and Richard Hollander, vice-president of packaging and device services at Pfizer, to find out more.

The global market for pharmaceuticals packaging is booming. According to the latest figures from MarketsandMarkets, the sector will be worth nearly $80 billion by 2018. For brands in this industry, the packaging and allied technologies they deploy will have to become smarter in order to meet legislative commitments and curb the rise of counterfeiting.

"We stand on the brink of a technological revolution that will fundamentally alter the way we address new healthcare solutions," says Richard Bergström director-general of the European Federation of Pharmaceutical Industries and Associations. "The use of new technologies will contribute towards significantly improving the management of acute and chronic diseases."

Global pharma

For brands in the pharma sector, the digitisation of healthcare means developing new technologies to meet the needs of customers. Invariably, this results in new forms of packaging developed specifically to meet serialisation responsibilities and patient adherence - all the while reducing costs.

Pharma companies have always been able to innovate with the packaging solutions they use. Last year, we saw an example of such innovation introduced by PhutureMed, partnering with E Ink: PhutureMed's new packaging solution offers pharma brands an intelligent pack that not only has a built-in display, but that can also communicate with a smartphone.

In another example of innovative pharma packaging, the Healthcare Compliance Packaging Council recently announced the winner of Compliance Packaging of the Year to be the Vertex ORKAMBI Medication Package from PCI Pharma Services. The packaging is compact and colour-coded, with a slotted design that makes the medication easy to remove.

Richard Hollander, vice-president of packaging and device services at Pfizer, tells Packaging Today: "Packaging plays a key part in complying with legislation, including the design of the artwork, the printing and inspection technology required, and the logic and architecture of the packaging line. The legislation should be followed in terms of physical systems and software, shipping and distribution, and the need to connect with worldwide systems.

"Some mandates - such as those in China and Korea - are already live, and others such as Saudi Arabia are expected to go live before 2018. The proposals suggested by legislative changes would allow a unified approach to packaging solutions across the pharma industry, to aid compliance and adherence thereby increase public confidence."

Serialisation

With the EU's Falsified Medicines Directive (EU-FMD) fast approaching, a key concern is whether companies across the pharma sector are prepared for the changes to come.

The new directive - due to come into force in 2018 - aims to tackle the rising quantities of counterfeit drugs across the EU. By empowering how drugs are monitored at the point of delivery, serialisation and unique pack identifiers can make it more difficult for counterfeit dugs to enter the legitimate supply chain.

"Pharma companies have to focus on meeting the serialisation requirements of various global markets, which are growing in scope as regulatory bodies look to better secure their supply chains," says Matt Whitt, head of packaging and life-cycle management at GlaxoSmithKline (GSK), "and packaging is fundamental to achieving serialisation solutions.

"Pack design and artwork can be used to accommodate serialisation codes and other data to comply with market regulations. Typically, this will involve updating artwork and printing/laser etching unique IDs onto the packs. GSK designs its packaging lines, logistics processes and systems to enable more efficient handling from vision inspection to order fulfilment."

Looking a little closer at the pharma manufacturing landscape, larger companies seem to be well placed with compliance planning. In partnership with their packaging developers and label converters, the needs of the EU-FMD are expected to be met in full by the deadline. However, when mid-level and smaller pharma companies are concerned, the speed at which they're moving forward with their serialisation compliance planning just isn't fast enough, and this may cause problems across supply chains when the new regulations come into play.

Brand-owners and manufacturers have, of course, always had a level of responsibility to consumers with regards to serialisation, but the level of traceability added by the EU-FMD is, in some cases, proving to be troublesome. Companies must look towards new developments that incorporate effective anti-counterfeiting solutions - such as tamper-evident closures or labels - while maintaining ease-of-use and attractive packaging designs.

Anti-counterfeiting
Counterfeit pharmaceuticals provide a challenge for every part of the supply chain: WHO states that 50% of the medications bought online are counterfeit.
For brands, active deterrents such as tamper-resistant labels are a first line of defence. These labels often work by causing irreversible damage to the print and cartonboard to which they are affixed (including varnished coatings) upon removal via opening. Other examples of anti-counterfeiting labelling include void-release labels, which leave a void message or pattern behind when the label is removed, and frangible film labels which disintegrate the label when its removal from the cartonboard is attempted.
Ian Lemon, global product director of health and personal care packaging at Essentra, says: "It is imperative that pharmaceutical companies are prepared to deal with the threat posed by counterfeiters, not only from a compliance perspective as a result of legislation, but also to protect their brand identity and do their part to help ensure patients are consuming the genuine medicine they require."

The Internet of Things
A survey by Capgemini Consulting revealed an average prescription-adherence rate of 69% for the first filling of a prescription, with a 40% drop for continuous refill after six months. The design and advanced technologies being implemented in pharma packaging can offer pharma brands and stakeholders a solution to this ongoing problem. Most significantly, perhaps, the much-heralded Internet of Things (IoT) could have a major impact on the fight against adherence levels across the pharma industry.

Whitt suggests that as IoT technology becomes more widely adopted, the pharma industry is seeing a convergence of packaging content and technology, for example, plus a link with smart assets such as mobile apps. This will, he says, "give rise to better patient engagement" by linking the physical pack with digital content that can be used for patient education and adherence. The rise of IoT also reveals the massive level of system infrastructure needed to support traceability across global supply chains. This will push some companies to look at cloud-based solutions.

"We will also see a move towards incorporating global standards into data architectures and packaging," says Whitt. "This will ensure that hospitals, pharmacies and other supply chain entities can process medicines in a standardised way.
"The possibilities enabled by such technologies mean pharma companies are coming upon great responsibility to decide how best to utilise new direct communication channels and how best to influence better adherence for patients. Emerging technologies can offer reminders and trigger signals to patients when they forget to take their medicine or are nearing a refill, for example."
In all areas, Whitt is clear that one of the most important elements of packaging development, entering the new realm of pharma over the next few years, is patient insight: it is vital to ensure that new packaging matches patient needs, and allows positive experiences and ease of use.

For brands, IoT will deliver a number of innovations, from data collection and analysis to remote access, and track and trace will become commonplace. New technologies will also continue to make packaging more interactive and able to communicate detailed information to patients. What's certain is that as the industry settles into new regulations and embraces new technology and design developments, pharma packaging is going to become a whole lot smarter.

Innovations in pharma packaging

As pharma responds to the wealth of new requirements brought on by EU-FMD and inter-industry pressures, innovative packaging formats and technologies are flourishing.

"In the primary packaging space we have seen introduction of desiccated foils that provide better moisture and humidity protection to solid dose products, and enable the removal of additional desiccant components. With these, we can expect to achieve better performance, and reduced complexity and cost. We have also seen a shift towards highlighting unit dose requirements as we have moved more to support emerging markets and the developing world.

"We are also seeing packaging become a communication channel, with QR codes linking to online content, visual graphics explaining device usage, or patient education information, for example. 3D-printed electronics such as labels that can read temperature information are also coming into use."

However, pharma companies are also under a lot of pressure when it comes to the development of packaging for their products. "Cost of goods is always a pressure point, and a good control point to ensure the balance of innovation and complexity," says Whitt. "Patient insights are a key area we explore when launching new medicines in new disease areas.
"We also seek to understand any constraints new patients or users of new medicines may have and how this should be considered in the packaging. We look at patient handling studies and incorporate inclusive design elements in order to maximise the patient population that will have a positive experience with our medicines. We are also under pressure to optimise patient adherence to prescription use direction, which we address through better communication and education via value-added packaging."