Child-Resistant Packaging: A Ghanaian Study Highlights Global Safety Challenges
Child-resistant closures (CRCs) on medication packaging are a cornerstone of pediatric safety in many countries, designed to prevent accidental poisoning. However, a recent pilot study conducted in Ghana, West Africa, reveals that the effectiveness and usability of these closures can vary significantly in different regions and populations. The research, published in the Journal of Applied Packaging Research, underscores the importance of considering cultural context and user capabilities when implementing safety measures globally.
The study, conducted by researchers at the Regional Institute of Technology, aimed to assess how well CRCs – specifically push-and-turn and squeeze-and-turn designs – functioned in a low-resource setting. While CRCs are effective in preventing unintentional pediatric medication poisoning in high-income countries, their performance and usability hadn’t been thoroughly explored in low- and middle-income countries (LMICs). Researchers adapted testing protocols used in the United States (16 CFR Part 1700.20) to evaluate the closures with a convenience sample of 50 children aged 42-51 months and 50 adults aged 50-70 years.
The results were encouraging for the youngest participants. A remarkable 98% (49 out of 50) of the children were unable to open the CRCs. This suggests that the closures effectively deterred access for this age group, mirroring their intended function. However, the adult portion of the study revealed a significant challenge. Only 72% of the adult participants (36 out of 50) could successfully open and close the test samples within the trial period. This falls considerably short of the 90% minimum required for Senior Adult Use Effectiveness (SAUE) as defined by US protocols, even though the sample size did not meet the 100-participant threshold for official reporting.
The findings highlight a critical disparity in usability. While the CRCs successfully prevented children from opening the containers, a substantial proportion of adults struggled with the mechanism. This difficulty isn’t merely a matter of inconvenience. the study authors noted that some consumers, unable to open the closures, resorted to using their teeth, knives, and other sharp objects, resulting in injuries like cuts and scratches. This underscores a potentially dangerous trade-off between child safety and adult access.
The study also revealed a broader issue: a lack of understanding regarding the purpose and function of CRCs among consumers in Ghana. Regardless of educational level, participants demonstrated limited knowledge of how the closures worked and why they were important. This lack of awareness, coupled with imprecise instructions on the packaging, contributed to the difficulties experienced by adults.
Despite these challenges, the study participants consistently identified CRCs as their preferred method for safe pharmaceutical packaging, recognizing their potential to protect children from accidental exposure to medications. This suggests a willingness to accept the usability challenges if it means enhancing child safety. The authors conclude that while consumers are hesitant to change the fundamental design of CRCs, improvements to opening instructions and increased pharmacist education are crucial for promoting correct and safe use.
This research builds upon previous investigations into consumer experiences with CRCs, as highlighted in a report from the Consumer Healthcare Products Association. The report, and similar studies, emphasize that the opening mechanism is a key factor influencing user acceptance. The Ghanaian study adds a crucial layer to this understanding by demonstrating how these experiences can differ significantly across geographical regions and socioeconomic contexts.
The World Health Organization and the Centers for Disease Control and Prevention (CDC) recognize child injury prevention as a global public health priority. Proven interventions, such as child car seats and helmets, are widely promoted. CRCs fall into this category, but their effectiveness hinges on appropriate design, clear instructions, and user education. The findings from Ghana suggest that a one-size-fits-all approach to CRC implementation may not be optimal.
The study authors emphasize the importance of applying the principle of justice in resource-limited regions. This means ensuring that safety measures are not only effective but also accessible and usable by the populations they are intended to protect. Further research is needed to explore adult usability and to develop CRC designs that balance child resistance with ease of access for adults, particularly in LMICs. The pilot study serves as a valuable starting point for informing global pediatric safety and usability standards, acknowledging that the needs and capabilities of consumers can vary significantly around the world.
