Ensuring that patients take the right medicine correctly and when they are supposed to is one of the biggest issues facing the pharmaceutical industry. It’s particularly relevant to the older generation, many of whom not only have reduced dexterity, strength and cognitive ability compared with their younger counterparts, but who also tend to be on far more complex drug regimes. While accessible packaging – a factor that can contribute significantly to this success – is becoming more commonplace, there is still room for improvement.
Enhancing adherence
Studies have shown that patient adherence (the extent to which an individual takes their medicine as prescribed) usually starts well but falls away over time, with the most dramatic drop-off between months one and four – even for disease areas with very low survival rates. The consequences of this can include medical complications, disease progression, hospitalisation and, in severe cases, death. Costs to the healthcare system also rise as the rate of patient adherence rates – which are currently at approximately 50% across diseases and health conditions – falls.
Many factors contribute to patient non-adherence. Recent Omnicell research in the UK on medication adherence found that two thirds of patients who didn’t take their medication as prescribed “forgot”; a quarter said the side effects made them feel ill; and a fifth claimed they no longer felt ill and therefore did not think they needed medication. But among these factors, packaging is crucial, particularly for those aged over 50.
Many older patients find that poor packaging can be a direct barrier to compliance with medication regimes, according to a presentation entitled ‘Patient Insights on Treatment Adherence in Oral Cancer Drugs (in chronic myeloid leukaemia (CML))’ by Giora Sharf and Jan Geissler, both co-founders of the CML Advocates network. The research found that the biggest problems seniors faced when opening packages were strength, lack of opening instructions and poor design.
Daily experience with patients, according to Geissler – writing for a white paper published by the Healthcare Compliance Packaging Council (HCPC) of Europe in 2015 – also shows that medications provided in bottles offer minimal behaviour support to memorise when medicine needs to be administered (elderly individuals often cannot recall whether or not they have taken their medication just minutes after having done so). In addition, a blister pack of ten doesn’t match weekly schedules, which reduces the probability of patients developing an effective routine, and large blister packs may deter patients who don’t want their condition to be known.
Low-tech solutions
All of these challenges and more can be addressed with inclusive and accessible packaging design – and without huge investment in technology. Well-designed calendar-style blister packs, for example, have been proven to improve adherence and can also help prevent overdosing. Some common features of these sorts of packs include compartments to divide monthly supplies into logical parts and windows to show the remaining product in the pack, which can have a positive effect on the refill rate of prescriptions.
Meanwhile, bigger openings, caps and tabs mean older patients with decreasing strength, dexterity and grip can still open their medication packs. “We’re good enough at closing packages; now we should be able to make packages that can easily be opened,” stresses Ger Standhardt, executive director of HCPC Europe, and manager of knowledge development and projects at the NVC Netherlands Packaging Centre.
In blister packaging, consideration also needs to be given to the size of each blister strip as well as the secondary packaging, to ensure packets are portable and discreet (sub-dividable units can be useful in this regard). Effective use of colours can also highlight important instructions and denote the strength of doses, while positive signs, signals and symbols can affect patients’ perception of their medication.
Finally, the inclusion of QR codes or website links, when combined with well-designed patient-centric packaging, can
also enhance engagement and therefore adherence. A link might connect an individual to a disease-management website, an auto-refill programme or even a mobile app from which they can get additional information or support.
Best-practice examples
The solutions exist, then, but is the industry making good enough use of them? According to Standhardt, using packaging to improve adherence is becoming a bigger focus, but there’s still more to be done. “That’s why HCPC Europe is here,” he explains. “It is an association that includes suppliers to and companies from the pharmaceutical industry that recognise the fact that more should be done when it comes to making packaging patient friendly. So many medicines are not used in the right way, and the focus from the beginning has been on improving therapy adherence with better packaging.”
One area in which the council has worked hard is improving regulations. For example, the team helped develop the ISO standards on accessible packaging and ease of opening, and is now working on a standard for information and marking.
HCPC Europe also uses its Columbus Award to identify any outstanding examples of patient-centric packaging across the industry. Now entering its tenth year, the prize rewards designs that include elements like colour-coding, clear instructions, visible evidence of medication taken, simple reclosing mechanisms, and discreet, portable pack shapes and sizes, and is open to projects that are under development as well as those that are already available.
Its most recent winner, UCB Pharma’s rheumatoid arthritis medication, Cimzia, not only looks friendly, with its clear text and positive colours, but also solves a common problem for users: the simple opening of the box and removal of the prefilled syringes within. Patients open the box by sliding their fingers under, then lifting, a curved front panel, after which three simple steps take them through the rest of the process. The tray also accommodates a wide range of dexterity limitations while the syringe is being removed, and the information hierarchy is clear and concise with a personal, conversational tone.
Meanwhile, the runner-up, Novartis’s diabetes product Eucreas, features a blister-size reduction to improve convenience, a separable daily dose, a sun/moon print to support adherence and rounded corners on the pack so that daily doses may easily be torn off. Other features of winning packages over the years include adherence books that deployed symbols and colours to help patients remember when to take their medication, and whether they have, and novel means of making complex dosing regimens as easily refillable and portable as possible.
The future’s smart
‘Smart’ packaging has huge potential for older patients. The term encompasses anything that uses technologies such as sensors and radio-frequency identification (RFID), which are not only able to deduce when packs have been opened and which pills have been taken and when, but can also link to mobile apps to alert users when subsequent doses are due.
The technology for adherence support is already here: E Ink’s PhutureMed solution, for example, can easily be integrated into a three-fold standard blister pack. RFID tells it when a patient has removed a pill and can trigger an alert if they forget. Thinfilm’s NFC OpenSense tags, meanwhile, can detect a product’s factory-sealed and opened states, and wirelessly communicate this information with the tap of an NFC-enabled smartphone. Similar innovations are undergoing clinical trials across the world.
The problem isn’t the technology – or indeed older patients’ lack of interest in it – according to Standhardt; it’s affordability. “Some say older people don’t know how to work smartphones or computers and don’t like all that technology, but actually most will be able to manage a smartphone, iPad or tablet with simple functions,” he notes. “The problem with smart packaging is the cost, and that’s one of the main reasons technology like this is currently in clinical trials rather than in mass production.”
Industry stakeholders such as the UK’s Centre for Process Innovation (CPI) are working specifically on this problem. Having recognised that many ideas won’t get beyond the conceptual stage unless the technology involved can reach industry standards of supply-chain efficiency and unit cost, CPI is providing companies with the infrastructure and support to trial new smart-packaging technologies without having to stop their own production lines.
The packaging projects
The REMEDIES project is particularly relevant to the pharmaceutical industry. Launched in collaboration with companies including GlaxoSmithKline and AstraZeneca in 2014, it was designed to develop and scale up smart-packaging concepts incorporating printed electronics, and is due for completion in March 2018. Until then, the partners will continue to work together to commercialise product prototypes and create a market-ready supply chain that enables mass-market adoption within the UK.
Meanwhile, the CPI team is also working with the likes of Unilever and Crown Packaging in a collaboration to commercialise NFC packaging. The key emphasis of the SCOPE project is to apply automated, high-speed integration techniques to deliver costs of less than 1¢ per NFC tag.
As Standhardt summarises, “It’s definitely an interesting field to keep an eye on. It’s all technically possible and is very relevant for older generations, as well as anyone acting as a caregiver who may also get a reminder if a patient’s pill isn’t taken at the right time. Development in this field is ongoing and it’s certainly improving, but the benefits are currently not big enough for the industry to cover the costs.”
Looking ahead, low-tech solutions are likely to dominate the market for accessible and inclusive packaging for the foreseeable future, with smart packaging an exciting possibility in the years to come. Meanwhile, for Standhardt and the rest of the HCPC team, their mission will continue.
“Our goal is to encourage companies to put more effort and energy into packaging,” he says. “After all, while there’s no packaging without the product, there is also no product without the packaging.
“Moreover, there is so much that can be done to improve patient adherence through improving packaging that even if it doesn’t pay back immediately in financial terms, it will pay back in the end.”
