Inclusive and accessible pharmaceutical packaging: a necessity for vulnerable patients

According to the UN's 'Word Population Outlook 2019' report, the number of people over the age of 80 will triple by 2050. These estimates make us reflect on the challenges of advancing age and encourage us to design products that take this into account, such as inclusive packaging solutions with a design that can be accessed and recognised by vulnerable users too.

Vulnerable patients

When we talk about vulnerable patients, we are not just referring to older people, but also to disabled people, patients suffering from complex chronic diseases and often with reduced self-sufficiency.

Taking an even broader view, another clinical definition of vulnerability also includes symptoms associated with mental health, including cognitive and social behaviour. According to this classification, vulnerability can be divided into three categories: physical vulnerability, cognitive vulnerability and psychosocial vulnerability.

The patient-centred approach in inclusive pharmaceutical packaging

Currently, most products, including packaging, are created with a so-called 'user-centred' approach, i.e. with a design method that primarily takes into account the needs of the end user and aims to make the user experience increasingly satisfying for everyone. ISO/IEC Guide 71:2014 is a guide developed precisely to ensure that accessibility standards are met in the design of products and their packaging.

Although this is true for the market as a whole, it is even more important in the world of pharmaceutical packaging. Designing pharmaceutical packaging for vulnerable patients means finding reliable solutions to ensure the administration of medicines to the elderly and to all those categories of patients who are not self-sufficient or are temporarily disabled, thus guaranteeing continuity and effectiveness of therapy.

The study 'Food Packaging Design Accessibility Guidelines' by Arthritis Australia defines a set of guidelines required to design and produce more inclusive packaging. Here are the top 10 that also fit the pharmaceutical packaging market:

• Guideline 1: Ensure that the product is easy to grip, so that it fits in the hand, and to control.
• Guideline 2: Provide a sufficient area to apply force to open or remove the packaging.
• Guideline 3: For products intended to be gripped with one hand, the gripping space must not exceed 71 mm, otherwise integrate additional systems to facilitate gripping.
• Guideline 4: Reduce the need for precision motor control.
• Guideline 5: Do not require the use of tools.
• Guideline 6: Avoid sharp edges.
• Guideline 7: Minimise the number of actions required to remove packaging.
• Guideline 8: Do not require simultaneous actions. For hazardous products, use smart opening systems instead of the typical push-and-turn cap.
• Guideline 9: If the packaging is intended to be torn, provide a perforated strip or serrated edges.
• Guideline 10: Provide a sufficiently wide grip point for openings.

Features of accessible pharmaceutical packaging

The primary function of pharmaceutical packaging is to protect the product it contains and facilitate its application, without the packaging’s safety requirements creating physical or intellectual barriers. If users have limited cognitive, visual or physical abilities, the operation of opening the packet and self-administering the drug may be impaired.

To overcome these problems, a number of accessible pharmaceutical packaging solutions have been designed:

1. Easy opening and use: often possible using just one hand and without excessive force or pressure;
2. Visible and intuitive directions for use: packaging with brighter coloured indicators and buttons, and larger, embossed pictograms for clearer and more visible instructions;
3. Simplified and self-correcting dosing and dispensing: e.g. bottles with a 'push&pump' function, which release the medicine in controlled doses with one simple push, and also allow liquid medicines to be consumed directly from the pack through a simple straw;

Smart pharmaceutical packaging: an accessible solution

Alongside the inclusiveness of packaging, a number of Internet of Things solutions are also being developed to make drug delivery simpler, better controlled and connected. Smart Packaging is a facilitating solution for all patients, but acquires an added value when we talk about vulnerable patients, as it becomes a useful tool for scheduling therapy, ensuring more accurate dosing and generally guaranteeing greater patient adherence.

In this area we find, for example:

• smart pill dispensers and ophthalmic nebulisers which, when connected to digital devices such as smartphones, can offer administration functions, often through very intuitive notification systems that guide the patient in how to correctly use the device. It is also possible to plan and pre-dose therapy, to aid individuals suffering from diseases such as Alzheimer's or cognitive-behavioural disorders.
• QR codes and RFDI technologies: can be transcribed directly onto packages and can be used to enable patients to access additional information, available in multiple languages or provided in a manner suitable for the deaf and visually impaired.

Accessible pharmaceutical packaging: a glimpse into the future

The development of pharmaceutical packaging has always been more oriented towards the protection of the drug rather than its ease of use, especially if one takes into account the numerous regulations obliging manufacturers to introduce tamper-proof closures.

Fortunately, today's R&D departments are increasingly aware of the need to find solutions that meet the needs of all patients, even and especially the most vulnerable ones. Pharmaceutical packaging has enormous potential to help improve patient experiences and pharmaceutical outcomes. Since 2014, the US Food and Drug Administration (FDA) has been trying to set the standard for a patient-centred approach, discussing the impact diseases have on their lives directly with patients. For this reason, the Patient Engagement Advisory Committee (PEAC), comprising patients, healthcare professionals and representatives of patient advocacy groups, was created. The aim is to increase the influence and level of participation of patients in decisions that directly affect their healthcare, from clinical trials to the administration of medical treatments.

It is therefore important to design inclusive packaging, because designing for the most vulnerable patients ensures a better user experience for everyone else as well.