A Pilot Study Evaluating Child Resistant Closures in Pharmaceuticals in the Developing Nation of Ghana: Informing Global Paediatric Safety and Usability Standards

Despite their proven effectiveness in preventing unintentional paediatric medication poisoning in high-income countries, the performance and usability of Child Resistant Closures (CRCs) remain underexplored in low and middle-income countries (LMICs). To provide pilot data regarding the potential efficacy of using CRCs in LMICs, we conducted a study of the approach in a low-resourced region (Ghana, West Africa) by adapting testing protocols utilized in the United States (16 CFR Part 1700.20). The study utilized a convenience sample of children (n=50; 42-51 months) and adults (n=50; 50-70 years) to develop preliminary data related to the efficacy of a single design of CRC common to commercial markets in the US (ASTM IA). Pilot testing results utilizing children were encouraging, as 98% of subjects (49 out of 50) were unable to open the CRCs. Of the 50 adult participants, 36 (72%) were able to open and close test samples within trial period. Although the sample size was not the 100 participants dictated under US protocol to officially report a Senior Adult Use Effectiveness (SAUE), our results were well below the required SAUE minimum of 90%. While limited by sample size and regional scope, the study fills an important gap in knowledge by formally recognizing and documenting the disparate application of the human principle of justice in resource-limited regions compared to industrialized nations, provides preliminary evidence that CRCs could be an effective strategy in protecting children in these regions documented to have higher rates of mortality and morbidity, and also suggests that usability for adults should be explored further prior to implementation.