According to the United States Food and Drug Administration, 10% of all pharmaceuticals sold globally are illicit.
In particular, counterfeiting places a strain on the developing world. According to the World Health Organization (WHO), 30% of all medicines in Africa and the Far East are estimated to be fake. This challenge is, in part, being addressed through tougher laws and regulations, which are being developed by governments across the world. Countries such as China, Turkey, South Korea, the United States and the European Union have been working to introduce legislation that aims to tackle counterfeiting by implementing serialisation and tamper verification requirements.
This new legislation presents manufactures with certain challenges, particularly when it comes to areas such as packaging, business structures, IT systems and supply chain management. Of course, the objective of this legislation is to ensure that patients have access to genuine drugs, and, when taken properly, these products can improve their lives. As a result, the priority for manufacturers has to be ensuring that any transition is seamless from a consumer perspective, ensuring that the changes do not impact patient adherence.
Alarmingly, this is already a major challenge: according to WHO, improving patient adherence to existing treatments would be more beneficial than developing new ones. Currently, 50% of patients with chronic diseases in developed countries do not take their medication as prescribed, and this figure is even higher in developing countries.1Financial burden
As a result, further financial strains are being placed on the healthcare sector; for example, research shows that patients not taking their medicines properly costs the UK’s National Health Service £500 million a year. To put it in perspective, this is roughly equivalent to funding 30,000 kidney transplants or an additional 21,000 qualified nurses.2
WHO explains that patients are not solely responsible for not taking their treatment, highlighting ‘five interacting dimensions’ that affect adherence. They suggest that there are other factors that affect people’s behaviour and their capacity to be able to stick to their treatment regimen, which are split into five categories: socioeconomic factors, factors associated with the healthcare team and system in place, disease-related factors, therapy related factors and patient-related factors.1
Now, packaging has the opportunity to improve adherence from a user perspective, with the WHO stating that patient-related factors refer to ‘the resources, knowledge, attitudes, beliefs, perceptions and expectations of the consumer.’
It is vital that patients have a fuller knowledge of their treatment to avoid misunderstandings. One way to increase the number of people who take their medicine correctly is to provide additional information and detail. The way information is delivered also improves understanding; for example, the use of graphics and illustrations alongside the thoughtful layout and organisation of material can improve comprehension.
Current industry trends towards long form instructions also pose both an opportunity and a challenge for drug owners, as consumers not only want more information, but also more variations of it, such as the same details in different languages or using graphics as well as words for easier access.
Extended content labels, booklet labels and leaflets are all popular ways of increasing space for information without compromising the size of packaging. Extended content labels are an efficient way to add further detail to medicine bottles, allowing patients to peel the labels back to access more information. Essentra, a leading global supplier of pharmaceutical packaging, has introduced both ‘Peel 2 Read’ (Figure 1) and ‘Peel and Reseal’ labels (Figure 2), the difference being that the latter can be resealed multiple times throughout its lifetime.Similarly, booklet labels are ideal for medicine bottles, allowing patients to scan through multiple pages of additional information about the product.
Figure 2: Extended content label
From a carton perspective, the inclusion of a multifold leaflet is fairly standard; however, opportunities exist for innovation as well. Essentra’s Plurium leaflet is a booklet style leaflet that is easier for users to navigate than map-style leaflets. The pages work like a book, allowing pharmaceutical companies the ability to design around the pages to improve content navigation. The leaflet also fits into standard packs, just like other leaflets on the market, meaning that manufacturers do not need to change their existing carton designs.
With this increased space, packaging can also incorporate other kinds of information, which should encourage patients to take their required medications: this can include data on ingredients, the efficacy of the treatment and possible adverse side-effects. For example, a recent poll by the ‘Let’s Take Care of It’ campaign and Omnicell, found that 36% of British adults believe that if the costs of medications to the NHS were provided on the packaging — a current government proposal — they would be more likely to take their drugs properly.2
Overall, information should be about reassuring patients, as well as simply instructing them on how they should consume the product.
The same report also found that 66% of those aged 55 or older said that they always read the label on their medicines; however, when it comes to young adults aged 18–24, this figure drops to 46%. Worryingly, one in ten people said they never read the instructions at all.2 This suggests that current instructions are not engaging enough. More aesthetically pleasing and interesting formats will encourage patients to engage, thus improving patient adherence.
In addition to a lack of knowledge, WHO also highlights ‘forgetfulness’ and ‘inadequate skills of managing treatment’ as patient-related factors that negatively affect adherence. It is one thing for patients to understand the need and benefits of taking the medication at the correct intervals, it’s another for them to remember to physically consume them. Clearly, there is a difference between these two factors, and this particular issue presents another opportunity for packaging manufacturers to change: by introducing products that help to indicate dosage unit and dates.
One popular solution to solve forgetfulness is calendarised packaging, particularly for once-daily, long-term medication. By printing dates by each pill in the blister pack, calendarised packaging acts as a visual reminder for patients. It also reduces the chance of overdosing or missing a dose, as patients are instructed to take one pill per day. Furthermore, calendarised packaging is often packed into 7, 14 or 30 pill blister packs to correspond to dosage cycles that last a week, a fortnight or a month, respectively.
The pack encourages patients to manage their consumption throughout the dosage cycle by clearly providing the exact amount of medication that is required. This positively impacts medication persistence — the act of continuing the treatment for the prescribed duration from initiation to discontinuation of therapy. Calendarised packaging has been described as an ‘active’ solution by The Healthcare Compliance Packaging Council (HCPC).3
It is also possible to incorporate microchips into calendarised blister packs, allowing manufacturers to enhance adherence though the use of innovative technology. These can be added to detect if and when medicine has been taken, beep to notify patients to take their medicine or even record responses to basic monitoring questions. The data that is recorded can then be downloaded onto the patient’s mobile device, allowing them to manage their own therapy and share the information with their doctors. The HCPC describe this type of packaging as an ‘interactive’ solution as it provides feedback and elicits a response from the patient.3
Packaging can generate a positive impact on adherence, by informing and supporting patients. However, it should be noted that packaging cannot be the only solution to the issue. While it provides a platform to improve adherence from a ‘patient-related factors’ perspective, there are often other external, social and economic factors that affect adherence. Therefore, packaging must be included as a part of a wider solution to address this major public health challenge.
To conclude, the most effective way to improve adherence is the implementation of multiple interventions. As a global leading supplier of pharmaceutical packaging, Essentra advocates a strategy of using several layers of solutions to maximise the intended patient outcome desired. With the EU Falsified Medicines Directive coming into force in 2019, the likelihood of patients receiving genuine medication should increase — the pharmaceutical industry must now place its efforts into ensuring that their patients take these authentic products correctly.
1. World Health Organization, Adherence to Long-Term Therapies: Evidence for Action: www.who.int/chp/knowledge/publications/adherence_full_report.pdf (2003).
2. Omnicell/Let’s Take Care of It, The True Cost of Medication Non-Adherence: www.letstakecareofit.com/wp-content/uploads/2015/10/The-True-Cost-of-Medication-Non-Adherence-Report.pdf (2015).
3. Healthcare Compliance Packaging Council, Improving Medication Adherence Through Packaging: www.hcpconline.org/member-news-document/HCPC-White-Paper-Improving-Medication-Adherence-with-Packaging.pdf.