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

Thesis for: Master, Advisor: Laura Bix

ABSTRACT 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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    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.
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    ABSTRACT: Other research has established seven UD principles and performance measures for the design and assessment of generic products. The objective of this research is to improve the suitability of UD for flexible packaging. The methodology used here begins by creating customer requirements from UD performance measures and packaging functions from JIS S 0022-4. The authors propose a correlation matrix to discard uncorrelated, duplicated and irrelevant requirements from the list of requirements. The remaining customer requirements are screened by using the Index of Consistency. Then, experts check and add essential customer requirements. A factor analysis is conducted on the survey data to find the important requirements and eliminate uncorrelated requirements. The number of customer requirements is reduced from 261 to 39 with five principles corresponding to UD. The five principles relevant to UD are (a) convenient, intuitive and simple use; (b) perceptible information; (c) structure and graphic design; (d) easy opening; and (e) equitable use. The benefit of the new five principles is not only the reduction from seven principles to five principles, but also the grouped customer requirements that are easy to use for packaging manufacturers and packaging designers. Customer requirements can be used as performance measures to evaluate the compliance of flexible packaging to UD. Finally, the application of the five principles and 39 customer requirements are demonstrated with case studies. Copyright © 2010 John Wiley & Sons, Ltd.
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    ABSTRACT: The objective of this research was to explore the perceptions and attitudes of two groups (older adults and people with disabilities) regarding child-resistant (CR) drug packaging. Six participants with disabilities and eight older adults participated in two separate focus groups. Analysis of focus group transcripts revealed two major themes. Firstly, tested designs did not clearly communicate. This failure related to both procedures for opening and information about the safe and effective use of the products. This was a problem of package affordance as well as unclear/confusing directions. The problem was further compounded for users who were blind or visually impaired. Secondly, requisite physical actions were challenging along many dimensions. Sometimes packages required too much force, while in other cases the size of the package or its features were too small.