Designing pharmaceutical packaging is no longer an afterthought, as manufacturers look to answer compliance, sustainability and counterfeiting concerns. Aarthi Janakiraman, analyst at Frost & Sullivan, explores how ‘smart’ techniques could hold the key.
The concept of ‘smart’ packaging is gaining momentum across industries and has various definitions and meanings. The most acceptable – and probably most apt – is ‘the conversion of normal packaging into intelligent systems that can perform multiple functions and benefit the consumer by helping them to understand the product’s functions’. The market can be broadly classified into two types: active and intelligent packaging, both of which have their own attributes. While the former packaging is based on the interaction between the molecules in packaging and the product, the latter uses electronic devices and sensors to communicate data to users.
Smart packaging arrived when UPC barcodes first appeared on packaging cartons. Such innovations have only become genuinely prominent in the last five years, though. Changes in consumer perception and market dynamics have increased the need for product differentiation, even in the pharmaceuticals (especially since the proliferation of biologics and generics) and smart packaging is often regarded as a reliable means of achieving this. This ability, along with a host of other features, such as improved traceability and monitoring, makes smart packaging popular among drugs companies and contract manufacturers.
Health creation
While smart packaging is becoming popular across various industries, its importance in the healthcare industry, especially to the pharmaceutical segment, is unparalleled. Here, the tight regulation of products means that innovation and quality are paramount. Legislative changes, new drugs and advances in technology have required appropriate changes in packaging.
Companies are under pressure to increase sustainability and use environmentally friendly materials, while responding to the multiplying opportunities presented by globalisation, making packaging more crucial than ever.
Smart packaging is useful across the healthcare sector. It can be used for threat detection (through monitoring humidity, temperature and possible contamination), diagnostics and for effective drug delivery.
It can also provide patients, pharmacists and healthcare professionals with valuable information about expiry dates, composition and dosages: benefits such as these make smart packaging poised for expansion in the near future.
Apart from the careful packaging required to shield drugs from damage or changes due to interaction with the atmosphere, smart packaging can help address challenges such as counterfeiting and patient compliance, while providing enhanced security.
In terms of technology development, innovations that cater specifically to a single segment of the pharma industry – Dispill’s multidosage system, for example – to innovations that also have applications in that sector, such as Clariant’s advanced desiccant polymers, are prevalent.
Counterfeiting is a global issue across supply chains, primarily in developing nations, and to a lesser extent in first-world countries). Statistics from the World Health Organization (WHO) estimate that 1-10% of all drugs sold are counterfeit, with cancer and heart medication among the most bootlegged. While US Governmental initiatives focus on ‘track and trace’ programmes for unit-level monitoring of drugs, using smart packaging across the entire supply chain will ease the life of companies, while increasing vigilance.
Cloud and clear
With companies such as Eli Lilly planning to invest around $100 million to prevent counterfeiting and improve traceability, integrating smart packaging with cloud-based tracking will help provide end-to-end monitoring across the supply chain, irrespective of geography.
For instance, some methods use purpose-built scanners to help thwart brand theft. The technology involves tagging drugs with labels during production-line packaging, and then registering with smartDNA high-speed scanning systems. Once registered, a product’s authenticity can be verified at any point in time, preventing counterfeit goods from entering the retail market.
RFID tags used in high volumes can prevent counterfeiting; chipless RFIDs are expected to offer extra benefits, such as preventing wrong dosage.
It has been noted that around 125,000 people with treatable ailments die each year in the US because of non-compliance of medication, while around 10% of nursing home admissions are due to the same issue, at a cost of $31.3 billion to the healthcare system. A report from Pfizer reveals a similar situation in Europe. The report states that non-adherence to medication costs around €125.0 billion (around $135.0 billion) for various EU governments annually. Encouraging compliance has thus become a major goal of healthcare systems, and smart packaging is expected to make it easier. For instance, it makes the conduct of clinical trials easier: new technology helps in accurately recording the time and date of every dose, estimating efficacy levels and increases the reliability of data collection and statistical interpretation. The technology can also be used for manufacturing pharmaceutical packaging with customisable cartons that contain dosage and medication information.
Smart packaging also has the potential to improve tamper-resistant packages (TRP), extending their use not only where anti-counterfeiting is concerned, but also as monitoring devices.
Worldwide legislation either mandates, or encourages, manufacturers to package their drugs, especially over the counter (OTC) ones, in TRP. Use of smart blister packs can lead to information exchange between the healthcare provider, patient and products with minimal intervention.
It can facilitate the gathering of data regarding compliance and information about dosage, and is able to communicate it across stakeholders, providing timely feedback for continuous patient monitoring.
One such approach involves blister packaging covered with electronic filaments connected at one end to a proprietary printed circuit board (PCB). The PCB, with the help of a time stamp, registers the removal of pills.
This data can be synchronised to a smartphone and used for monitoring, either by the patient or the healthcare provider.
Smart packs can also transmit data to centralised databases, storing them for use by future analysis.
Smart packaging also helps address concerns about possible memory lapses and mediation errors, especially in elderly patients, either by personalising cartons as unit dose packages (UDP), or making them act as smart dispensers that can issue correct doses, at the right times.
Innovations in UDP packaging can also provide visual cues for renewing prescriptions and act as reminders to take medication.
Seeing is believing
Another key trend is information legibility, which is becoming more important as the population ages: the focus is on increased use of visual aids for conveying important information.
According to Frost & Sullivan’s analysis, the US pharmaceutical market revenue was around $13.90 billion in 2013, and is expected to grow at a CAGR of around 5.3% for the next five years, with the US, Western Europe and Japan accounting for around 65-70% of the world’s pharmaceutical packaging. This is expected to shift towards Brazil, China and India as the generics and CRO markets expand. There is also a perception that increasing demand for smart packaging in certain developed nations is partly due to the influence of (Australian-based packaging company) Amcor there.
By 2017, serialisation of pharmaceutical packages, as well as evidence tampering, will be required in the European Union. A balance must be struck between safety, cost-effectiveness and legal compliance. These factors are expected to increase the adoption of smart RFID tags, chipless barcodes and related technologies, such as the metal-crimped vials equipped with radio-frequency identification (RFID) made by MEPS Real-Time (US) and Schott (Germany).
In the US, the market for smart blister packs is expected to increase, mainly due to an increase in OTC drugs and generics. This paves the way for technologies like the kind used for Noven Therapeutics’ menopause drug, Brisdelle. The design features a calendar-based dosing system for 30 days of therapy, with an area in which the patient notes the starting date.
Mass effect
Growth in generics and CROs in the Asia-Pacific region, especially in China and India, which are emerging as most sought-after markets, will increase the adoption of smart packaging to improve traceability across supply chains and prevent counterfeiting by increasing the use of RFID tags and chips connected to cloud-based monitoring systems.
The future looks promising for smart packaging in the pharmaceutical industry, but there are still many hurdles for it to clear before it is adopted on a wider scale, one of which is cost. Smart packaging isn’t cheap: the entire system, from the choice of material to production and storage, is expensive compared with conventional packaging and the extent to which this will be passed onto consumers is a major issue.
Focusing on developing items that can be used across segments will help control cost. A main advantage of smart packaging is that it enables the manufacturer to choose whether the packaging should be developed for an entire product line, or on a case-by-case basis. Another key issue is that packaging is often crucial to a drug’s success, so careful planning and choice of materials, design, equipment and processing is vital.
From an industrial perspective, smart packaging can result in increased collaboration between technology providers and packaging manufacturers, which will help market growth. It will also introduce new stakeholders, such as electronic component manufacturers and IT service providers, into the value chain, changing the industry’s dynamics. The most important factor in the success or otherwise of smart packaging is its ability to inspire consumer confidence and thereby gain acceptance.
The pharmaceutical industry is increasingly driven by service, rather than supply, and smart packaging is one way to smooth this rapid transition. It isn’t about reinventing the wheel, but rather driving pharma towards a patient-centric approach that provides consumers with the means and devices to improve their ability to access and use products.