Ageing and Accessibility: A Demographic Challenge
The shift in the demographic makeup of the Asia-Pacific is one of the most significant of the twenty-first century, with profound implications for healthcare systems [3] and pharmaceutical markets. Japan not only leads the region’s ageing trends, but the world’s, with approximately 29% of its population aged 65 and up as of 2024; comparatively, in South Korea, Singapore, Thailand and China, populations are ageing at a rate which will in elderly populations of over 20% within the next decade. This creates expanding markets for chronic disease medications which disproportionately affect elderly populations, simultaneously creating imperatives for packaging designs to accommodate older adults’ physical capabilities and limitations.
Limitations such as reduced manual dexterity, visual impairment and cognitive decline all need to be factored into the packaging design of any medication geared towards an ageing population. However, these physical issues also make traditional child-resistant packaging like push-and-turn-closure bottles or blister packs more challenging to use. Research examining the opening capabilities of children and elderly adults has documented substantial overlap in their physical capabilities, with some elderly adults possessing grip strength and manual dexterity comparable to or less than children aged between 4 and 5.
The implications of inaccessible packaging on medication adherence are substantial, encouraging elderly patients to skip doses if they are unable to open containers, or require external assistance in doing so which may not always be available. At the same time, these packaging solutions will need to be child-resistant and prevent cross-contamination and environmental degradation. This gives pharmaceutical companies a serious imperative to devise and implement packaging designs that are truly accessible for all.
Regulatory Frameworks Governing Child-Resistant Packaging in the Asia-Pacific
ISO standards have created consistent criteria to define packaging safety across international markets, which serves as the basis for many regulations within the Asia-Pacific. For example, the tests which established the ISO 8317 [4] standard required that at least 85% of children aged between 42–51 months cannot open packaging within a five-minute test period, while at least 90% of adults aged 50–70 years could open and properly reclose the same packaging. This dual performance requirement explicitly recognises the need to balance child resistance with adult accessibility, but Asia-Pacific markets may need to conduct further safety tests to ensure that pharma packaging can address the capabilities of its rapidly growing oldest population.
Japan's Pharmaceutical and Medical Devices Agency has implemented child-resistant packaging requirements for certain categories of high-risk medication, with regulations more aligned with the country’s specific physical and cultural preferences. The country’s regulations emphasise the need for clear labelling which provides unambiguous instructions for proper package opening and reclosing procedures, spotlighting the importance of both mechanical design and user understanding for product safety. China, by contrast, has not outlined comprehensive mandatory requirements around child-proofing its packaging, but the country’s National Medical Products Administration has issued guidance for pharma companies on a more voluntary basis.
Meanwhile, with its sprawling pharmaceutical regulatory framework, India has traditionally overlooked accessibility and child-resistance in its pharma packaging. However, rising awareness of the risk of paediatric poisoning, coupled with a drive for better alignment with international regulatory bodies, has led industry conversations in an encouraging direction. However, India’s pharma distribution network is fragmented, with pharmacists often dispensing medication separate from its original packaging, which creates a challenging environment for authorities to put measures of this nature into place.
Balancing Safety and Accessibility for Innovative Design
Pharmaceutical packaging engineers have developed a range of design approaches in an effort to reconcile the twin needs of child-resistance and senior accessibility. These are more reliant on cognitive differences between children and adults, rather than their physical capabilities, such as written instructions or visual cues, which creates a barrier to entry for children, while not excluding older users. One such example of cognitive design is the reverse-logic closure system, which requires users to push down and turn simultaneously to open a container; these closures can be designed with relatively low torque requirements, to accommodate users with reduced grip strength, while continuing to maintain effective child resistance through its relative operational complexity. As long as instructions are presented clearly, these reverse-logic designs could be a possible step towards a safer and more inclusive future for pharma packaging.
Peel-push blister packaging, which incorporates perforated backing materials to peel away rather than pushing through a foil seal, has also become a viable alternative to traditional push-through blister formats. This addresses concerns around require finger strength and precision which is not always viable for older patients, but retaining the same unit-dose integrity and tamper evidence as its more familiar version. Peel-push designs do, however, require their materials to be carefully selected, to prevent the top layer from being too easy to peel.
Dual-access packaging systems incorporate both child-resistant and easy-open features, letting users choose the appropriate access methods for their household circumstances. Specifically, this packaging will incorporate a child-resistant closure as its primary access mechanism, with an alternative easy-open feature for situations where there is no chance a child would be able to access the medication. Dual-access systems have been accepted as a packaging system by some regulatory bodies, though concerns remain about the easy-open feature being too accessible to be considered child-resistant.
