The Use of a Universal Design Methodology for Developing Child-resistant Drug Packaging

Thesis for: Master, Advisor: Laura Bix


People with disabilities and older adults are significant consumers of prescription drugs. However, most testing protocols for child resistant (CR) packaging do not take these individuals into account. One example is the United States Consumer Products Safety Commission’s (CPSC’s) protocol that excludes people with any obvious disability from the “senior-friendly” test. Instead of forcing manufacturers to develop CR packages that people with difficulties can use, the government permits pharmacies to dispense drugs in non-CR packages upon request, and allows the manufacturers of over-the-counter medications to package one size in non-CR packages. This assumes that people with disabilities do not live with children, and thus limits their choices.
For this research, a user-centered methodology that follows the universal design principles, guidelines, and methods was crafted. Universal design is an approach that addresses the needs of the widest possible audience; by applying its principles to CR packaging, users with a wider range of abilities can be accommodated. Three working groups were at the core of this process: people with disabilities, older adults, and children. Four distinct areas (hand strength, hand-finger dexterity, hand anthropometrics, and cognitive abilities) have been identified that can be employed to defeat children while allowing adults easy entry to packages. This information has the potential to guide designers not only in design choices, but also in dimensional and force related decisions regarding CR package design.

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    • "PWLs were attached in vertical position to 10 dram vials with a 1-clic® type closure (Figure 1a). Previous publications have indicated this vial size to be the most commonly used in the United States [46]. Along with the vertically placed PWL’s, the vials also contained a standard, white, pharmacy label which was generated by the campus pharmacy that included: dosage, drug and patient information (see Figure 1b). "
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    ABSTRACT: Adverse drug events (ADEs) are a significant problem in health care. While effective warnings have the potential to reduce the prevalence of ADEs, little is known about how patients access and use prescription labeling. We investigated the effectiveness of prescription warning labels (PWLs, small, colorful stickers applied at the pharmacy) in conveying warning information to two groups of patients (young adults and those 50+). We evaluated the early stages of information processing by tracking eye movements while participants interacted with prescription vials that had PWLs affixed to them. We later tested participants' recognition memory for the PWLs. During viewing, participants often failed to attend to the PWLs; this effect was more pronounced for older than younger participants. Older participants also performed worse on the subsequent memory test. However, when memory performance was conditionalized on whether or not the participant had fixated the PWL, these age-related differences in memory were no longer significant, suggesting that the difference in memory performance between groups was attributable to differences in attention rather than differences in memory encoding or recall. This is important because older adults are recognized to be at greater risk for ADEs. These data provide a compelling case that understanding consumers' attentive behavior is crucial to developing an effective labeling standard for prescription drugs.
    Full-text · Article · Jun 2012 · PLoS ONE
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    • "" (Marshall, 2005) The traditional approach to package design involved little to no quantification of the human/package interface or usage conditions; packages that were created through significant consumer input were heavily marketing driven, considered proprietary and, therefore, generally not published. It is only during the last 15 years that research has emerged that quantifies the human/package interface with commercially available packages by using established techniques from fields such as biomechanics, kinesiology, occupational therapy, and ergonomics (Yoxall et al., 2007; Kou, 2006; de la Fuente, 2006; Yoxall et al., 2006 ; Langley et al., 2005; Saha, C and Shehab, R. 2005; Okunribido and O; Haslegrave, 2003; C. Crawford, 2002 ; Voorjbi et al., 2002 ; Arnold, 1990) The available research generally focuses on quantifying the forces involved when people open packages of a variety of types; little has been done to map the surface area of touch as people interact with packages. However, understanding the area of contact is important for several reasons. "
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    ABSTRACT: Current trends indicate that consumers are looking for convenient and easy to use products. Product designs that are created with the consumer in mind can provide manufacturers with a competitive edge. Methods that quantify and qualify the human package interface are needed. This study compares two tests that quantify the surface area of contact between people and the packages that they use. The "lifted handprint" (LH) and the "three dimensional tracing" (3DT) methods were each used with 65 subjects to quantify the surface area of touch. The average surface area across all replicates and subjects, as calculated using the LH technique, was 35.00 cm 2 ; the average surface across all replicates and subjects using the 3DT method was 41.81 cm 2. To examine the null hypothesis, " there is no difference in the measured contact area of the hand and package when quantified with the lifted handprint and the three-dimensional tracing methods, " a paired t test was conducted with the usable data set (n=65). Paired t test results indicated that a significant difference existed between the area returned by each method (p<0.0001). A Pearson correlation coefficient was calculated to examine the correlation of the two methods. Results indicated a high correlation (r=0.90853) between the surface area quantified by the lifted hand method and the three-dimensional tracing method. This work represents a first step in quantifying the human/package interface.
    Full-text · Conference Paper · Sep 2007
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    ABSTRACT: Research has documented the drastic reduction of unintentional poisonings of children since the introduction of child resistant (CR) packaging. However, studies also indicate that consumers report difficulty using CR packages, in part because tests which determine the 'senior friendliness' of CR designs that are used throughout the world disallow people with 'overt or obvious' disabilities from being test subjects. Our review of drug package usability suggests that the current tests of CR packaging can and should be revised to correct this problem. We use US legislation, regulation and data to exemplify these points, but the conclusions are applicable to all protocols that include the exclusionary provision.
    Full-text · Article · Aug 2009 · Health expectations: an international journal of public participation in health care and health policy
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