Unintentional medication exposure and associated consequences remain a problem for populations under the age of five. Despite the progress made from the requirement for child resistant closures, a significant number of children are seen in Emergency Departments or hospitalized each year. Our goal was to develop flow restrictive (FR) devices for prescription vials, to provide a passive barrier to unintentional exposure; successful designs will reduce or eradicate the adverse consequences of unsupervised ingestions. A survey of stakeholders across the pharmaceutical supply chain (IRB STUDY00008016) was conducted to inform the development of two novel FR designs. Designs were produced with 3D printing and tested using instrumentation and a methodology developed by the research team. The test apparatus and method were informed with a task analysis conducted on 19 videos of 41 children ages 2-5 years old interacting with prescription vials in order to determine the types of rigors packages were subjected to. Analysis of efficacy results for FRs examined: regimen (start middle and end), pill morphology (round or oblong) and designs; results are reported within. Removal force was measured using an Instron Universal Testing device, and measured results were compared against a calculated removal force to provide evidence that FRs would not dislodge during shaking. FRs were tested using CPSC’s small parts testing fixture yielded evidence to support that the proposed designs are not a choking hazard. In doing this work, we provide proof of concept relating to the efficacy of two FR devices in reducing flow, address many of the concerns that could be raised relating to them as a proposed solution and provide a foundation for methodologies that could be used to evaluate the efficacy of novel designs that may emerge.
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