The pharmaceuticals and packaging industries need to engage on smart packaging because pharmaceuticals are predicted to be the single largest growth market for smart packaging, which is itself growing at 8%/year overall. So said Chris Waterhouse of iDi Pac at the Packaging Innovations show at theNEC in Birmingham, UK, on March 1^st, 2017.

“The packaging world has much to offer the world of pharma. That’s the reality,” Waterhouse said. The audience itself was overwhelmingly from the packaging industry; the event, actually five co-located exhibitions, had very few pharma-specialized exhibitors.

Smart Packaging

The term ‘smart packaging’ refers to packaging that adds previously unavailable functionality through intelligent (i.e. a communication element that informs the consumer about some change in a product’s condition or additional information) or active (i.e. improving the protection level, notably through interaction with the product) means.

Multiple complex and interlinked factors are driving the growth of smart packaging:

• Legislation, e.g. serialization, tamper evidence requirements, etc.
• The growth of self-medication
• The growth of biological medicines
• The increasing value of medicines themselves
• Increased remote communication between patients and doctors
• The growth in data sharing, in clinical trials, diagnostics, etc.
• Anti-counterfeiting
• The increasing complexity of treatments
• Malpractice suits, already a huge issue the U.S. but growing elsewhere too
• Child resistance requirements

“What is bringing all this together?” Waterhouse added. “The Internet of Things - the network of physical devices and connectivity that is allowing us to start a data flow around the world and bring it to the doctors, patients and supply chain to get to a point where things are more reliable and accurate and, hopefully, to improve the outcomes.”

Opportunities are seen for smart packaging in many areas. The key ones, in Waterhouse’s view, are promoting patient adherence, anti-counterfeiting protection, data collection, communications, shelf impact and presence, product image and personalized medicine.

Estimates are that non-adherence, i.e. not taking medicines in the right quantities, at the right time and within the right period of the prescription, costs about $300 billion/year in lost days, hospital stays etc. and also results in about 125,000 deaths/year in the U.S. The scale of the issue is probably similar in Europe.

For every 100 prescriptions, according to a U.S. study, 50-70 are filled at the pharmacy and 48-66 are collected by the patient. Even when they are collected, 25-30 of the original 100 are taken properly and only 15-20 are refilled as prescribed.

“In principle, every pharma company in the world could double its sales without doing anything else but making sure that people take their drugs at the right time. That’s a huge opportunity and packaging has a great place to work in,” Waterhouse said.

In another recent study of respiratory drugs — a $40 billion/year market globally – adherence levels were estimated at 43%. Based on the reasons given for non-adherence, the patient forgetting (24%) represents $5.5 billion in lost value, fear of the side effects (20%) another $4.6 billion and the effects on the disease (14%) $3.2 billion.

Getting it Right

“There are huge potential benefits in getting things right,” Waterhouse said. “58% of non-adherence can be attributed to lack of information or poor communication. This is likely to be an issue of the pack talking to the patient. So, through communication, we can start to address this. This is where the packaging industry can start to have a real impact on outcomes for the patient.”

Adherence can be promoted through smart packaging in several ways: smart primary packs with visual or audio reminders; NFC and RFID systems with links to smartphones – these are especially useful in diagnostics; and, using smartphone technology for reminders and ‘augmented reality’, such as helping patients to take drug at right time or show them where to insert the diabetes needle, or informing relatives about missed doses.

“It’s all about using the technologies that are available to us and bringing them together in a pharma field. A lot of this stuff is not necessarily expensive, it’s about linking things together,” Waterhouse observed.

Smart packaging can also help to improve adherence through feedback and communication, by capturing more patient information, such as how he feels throughout the course of treatment, not just when speaking to the doctor towards the end of it. This can help the doctor in turn.

Looking Outside Pharma

Another opportunity for smart packaging is in the cold chain for biologics. Here, Waterhouse said, pharma might learn from the food industry in managing products throughout their complex supply chains. Smart sensors can verify product integrity, establish that products are in-date or understand where shocks occur, for example. Temperature stickers and smart labels are already used.

The big challenges come down to the choice of technologies, their limitations and legislation. On-cost and end-of-life disposal issues arise. Many of the technologies are driven by batteries, which generally have shorter lives than drugs do. With emerging markets driving the growth, addressing that demographic is a big challenge too.

“What about codes? It will also not be enough just to add another 2D code to a package to feedback information to the internet when we have just added serialization,” Waterhouse said. “So, do we have to do more NFC and/or RFID work? How do we deal with that? What about data security, patient perceptions regarding privacy and personalized data? How do we take it all forward?”

Towards Tomorrow

The future, in his view, starts with smart diagnostics for optimum dosages. We will also see infinite dosages based on individual patient attributes. Packaging firms cannot deal with that alone. Personalization of drugs, formulae and information, with 3D-printed combination drugs and smaller batches – maybe even of one – pose a huge challenge.

“How do you get to that world where every person is unique and it is down to individual doses? What price an Amazon fulfilment system for your personal dosage? It’s not a million miles away. Amazon can do stuff overnight, so why wouldn’t you do your drugs like that? Assuming you want to pick up your drugs from a warehouse, but that’s another story.”

Likewise, global connectivity, Waterhouse said. There could in effect be a global dispensary or regional ones based on replenishment and reduced stocks. “That could go either way, taking things away from packaging or towards a world of late-stage personalization systems.”

Other issues include making medicine more palatable and convenient, plus embeddable technology, which may or may not be seen as a form of packaging. Implants that can be turned on and off by wireless — raising ownership issues — and microchips to detect changes in patients’ physical state are already happening.

“We are scratching the surface but with packaging we can do so, so, so much more” Waterhouse concluded. “Cost is an issue but smart packaging will result in treatment with better outcomes and better security and improved information flows that will do much to optimize dosage and treatment levels”.

“The Internet of Things will provide the connectivity to drive those sorts of treatments and Big Data will need to be managed and accessed securely to make it work. The BRIC countries and other emerging markets will drive the growth forward and it will almost certainly exceed our expectations. There are massive opportunities out there and we should be trying to leverage them.”