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3.1
22709 LIBRARY
MICI'n‘U - State
University

 

 

 

This is to certify that the
thesis entitled

DESIGNING A SENIOR FRIENDLY AND
CHILD-RESISTANT OTC/PHARMACEUTICAL SOLID ORAL
MEDICATIONNITAMIN SUPPLEMENTAL
ORGANIZER/DISPENSER PACKAGE

presented by

AMY SUZANNE HOUGHTALING

has been accepted towards fulfillment
of the requirements for the

MS. degree in Packaging

 

Majofirof 'or’s'Signature

30 A gr} I) ZOO‘I

 

Date

MSU is an Affirmative Action/Equal Opportunity Institution

PLACE IN RETURN BOX to remove this checkout from your record.
To AVOID FINES return on or before date due.
MAY BE RECALLED with earlier due date if requested.

 

DATE DUE

DATE DUE

DATE DUE

 

JAN "2 o 2014

 

 

 

 

 

 

 

 

 

 

 

 

 

2/05 p:lClRC/DateDue.indd-p.1

 

DESIGNING A SENIOR FRIENDLY AND
CHILD-RESISTANT OTC/PHARMACEUTICAL SOLID ORAL
MEDICATION/VITAMIN SUPPLEMENTAL
ORGAN IZER/DISPENSER PACKAGE

By

Amy Suzanne Houghtaling

A THESIS
Submitted to
Michigan State University

In partial fulfillment of the requirements
For the degree of

MASTER OF SCIENCE
School of Packaging

2004

DESIGNING A SENIOR FRIENDLY AND CHILD-RESISTANT
OTC/PHARMACEUTICAL SOLID ORAL MEDICATIONNITAMIN
SUPPLEMENTAL ORGANIZER/DISPENSER PACKAGE
By

Amy Suzanne Houghtaling

According to the US. Consumer Product Safety Commission, more than 600,000
older Americans are treated each year in hospital emergency rooms for injuries acquired
at home. Approximately 10 to 25 percent of these injuries are caused by medication
noncompliance (Smith, 1989).

There is evidence that suggests medication noncompliance is partially attributable
to reduced cognition and hand dexterity, which is more common with the elderly
population. However, people of all ages and abilities experience difficulty in using
packages, such as child-resistant packages.

For this research, a solid oral pharmaceutical/OTC dispenser/organizer package
was designed that requires minimal hand dexterity, while remaining child resistant. This
newly designed package dispenses daily medications with the use of two fingers on the
same hand.

A nonworking prototype of the package designed for this research was evaluated
using 100 test subjects, individuals with and without disabilities, to obtain data that
would be useful for the package research and development process.

By designing a package that is easy to use for people with and without

disabilities, medication compliance can be improved.

Copyright by
AMY SUZANNE HOUGHTALING
2004

For my wonderful husband Kevin, our son Tylor,
my parents Robert L. and Elise A. Berger,
my siblings Wendi, Noah, Jared, and Molly
and my grandmother Dorothy Berger (1912 — 2000),

with love.

iv

ACKNOWLEDGEMENTS

“Behind every initiative and every accomplishment there is a team of people dedicated

to the success of the student and their research.” — Author unknown

During my years of study, there has been much support from many people,
including family, fiiends, professors and people in the packaging industry. Many people
have influenced my work in a very positive way. My sincere thanks go to all of them.

Professor Harold A. Hughes, Ph.D., my major professor, was happy to provide
me with the guidance, resources, and tools I needed during the process of this research,
which included a visit to the 3D Media Center on the campus of the University of
Michigan, Ann Arbor, Michigan, to see, first hand, the technology of rapid prototyping,
a process used for the creation of prototypes. His open-mindedness allowed me to
explore creativity and imagination in package design.

Professor Laura Bix, Ph.D., a valuable committee member, provided excellent

resources and guidance on human factors, as well as enabling my package design to
obtain needed protection by putting me in contact with Mr. Bradley Shaw and Mrs.
J anyth Sherman at the Michigan State University Office of Intellectual Property. Dr.
Bix also directed me towards invaluable package testing resources, such as Ellen
Weaver and Paula Rehner of the Capital Area Center for Independent Living.

My thanks also go to rheumatologist Dr. Robert C. Shephard, MD. and his

fiiendly office personnel for providing me with many arthritic test subjects.

Professor Hugh Lockhart, Ph.D., another valuable committee member, also has
my gratitude. His knowledge of pharmaceutical packaging has proven to be an
invaluable part of my research. He extended my mind to the many regulations involved
in packaging and the product being packaged.

Professor David Zachary Hambrick, PhD., from the Department of Psychology,
also a valuable committee member, provided me with guidance, resources, insight, and
humor that augmented and increased my knowledge of cognition, such as the cognitive
skills that influence package use and medication compliance.

Mr. Javier De La Fuente, an industrial designer and fellow packaging student,
provided his expertise for the mechanical development of my package; from the making
of the package model to the three-dimensional computer generation of my package
design. He has been a very important part of my research.

Professor Bruce Harte, Ph.D., Professor Susan Selke, Ph.D., Professor Robert
LeMoreaux, PhD., as well as the rest of the packaging faculty and staff, provided
guidance, resources and friendship, as well as broadened my knowledge of packaging
and the packaging industry through courses and assistantship opportunities.

I would also like to thank fellow students and friends Napawan Kositruangchai,
Krittika Tanprasert, Hsin-yen Chung, Uruchaya Sonchaeng, Dario Martino and other
friends in the School of Packaging for their friendship.

My deepest gratitude goes to my husband, Kevin, our son Tylor, as well as to
my parents Robert L. and Ann E. Berger, sisters and brothers, Wendi, Noah, Jared and
Molly, and their families, whose love, enthusiasm and support enabled me to pursue and

to complete my research and education.

vi

TABLE OF CONTENTS

LIST OF TABLES ........................................................................................................... ix
LIST OF FIGURES (Some images in this thesis are presented in color) ......................... x
INTRODUCTION ............................................................................................................ 1
CHAPTER 1: LITERATURE REVIEW .......................................................................... 4

Why Design a Consumer-Friendly and Child-Resistant Pharmaceutical/OTC
Organizer/Dispenser Package? ..................................................................................... 4

Why Design a Consumer-Friendly and Child-Resistant Pharmaceutical/OTC
Organizer/Dispenser Package for the Aging Population? ............................................ 5
Medication Noncompliance ...................................................................................... 5
Child Safety .............................................................................................................. 6
Physical and Cognitive Changes Associated with Aging ......................................... 7
Prevention of Age-Related Cognitive Declines ...................................................... 21
Guidelines for Consumer-Friendly Package Design ................................................... 22
Universal Design ..................................................................................................... 22
Human Factors ........................................................................................................ 23
CHAPTER 2: DESIGN AND DEVELOPMENT PROCESS ........................................ 35
Inspiration ................................................................................................................... 35
Package Design Development .................................................................................... 38
Sketches .................................................................................................................. 39
Package Design Illustration .................................................................................... 40
Model ...................................................................................................................... 41
Nonworking Prototype ............................................................................................ 44
New Package Features ............................................................................................ 48
How Package Works ............................................................................................... 48
Child-Resistant Feature ........................................................................................... 49
Intangibilities .......................................................................................................... 49
CHAPTER 3: MATERIALS AND METHODS ............................................................ 50
Package Prototype ....................................................................................................... 50
Rapid Prototyping Technology ................................................................................... 53
CHAPTER 4: TEST PROCEDURE ............................................................................... 55
Subject Orientation ..................................................................................................... 55
Collection of Subject-Related Information ................................................................. 56
CHAPTER 5: RESULTS AND DISCUSSION .............................................................. 59
Section 1: Test Subject Age Range and Sex, and Physical Condition Categories ..... 60
Test Subject Normal and Secondary Physical Condition ....................................... 60

vii

Test Subject Physical Condition per Age Range .................................................... 61

Secondary Test Subject Physical Condition ........................................................... 62
Section 2: Test Subject Feedback on Specific Components of the Newly Designed
Organizer/Dispenser ................................................................................................... 63

Package Method of Use was Easy to Understand ................................................... 63

The Feel of the Handle is Comfortable ................................................................... 64

The Distance of the Two Buttons is at an Adequate Distance Apart ...................... 65

The Distance of the Buttons is Comfortable for Individuals with Decreased

Physical Hand Dexterity, Such as Gripping or Pinching Strength ......................... 66

This Package will Aid in Medication Compliance for Both Individuals with or

without Physical Hand Dexterity ............................................................................ 67

If Manufactured, I have a Desire to Own and Use This Package ........................... 68

CHAPTER 6: CONCLUSION AND FUTURE STUDY ............................................... 69
Conclusion .................................................................................................................. 69
Suggestions for Future Research ................................................................................ 7O

Child-Resistance ..................................................................................................... 70

Solid Oral Requirements ......................................................................................... 70

Increased Independence for Mentally Handicapped Individuals ............................ 71

Compliance Packaging ............................................................................................ 71

APPENDICES
Appendix 1: Human Percentile Conversions .............................................................. 72
Appendix 2: ZPrinter 310 System ............................................................................... 75
Appendix 3: Sketches ................................................................................................. 77
Appendix 4: Package Drawings .................................................................................. 86
Appendix 5: Consent and Confidential Agreement Forms ....................................... 105
Appendix 6: Questionnaire ....................................................................................... 110
Appendix 7: Questionnaire Data ............................................................................... 113

Section 1: Secondary Test Subject Information .................................................... 114

Section 2: Test Subject Solid Oral Medication/Vitamin Supplement and Quantity

Use ........................................................................................................................ 122

Section 3: Normal and Secondary Test Subject MedicationNitamin Supplement

Packaging Use ....................................................................................................... 134

Section 4: Normal and Secondary Test Subject Child-Resistant

MedicationNitamin Supplement Packaging Ease of Use .................................... 142

Section 5: Normal and Secondary Test Subject Medication/Vitamin Supplement

Solid Oral Organizer Use ...................................................................................... 146

Section 6: Normal and Secondary Test Subject Medication/Vitamin Supplement

Solid Oral Organizer Preference ........................................................................... 150

Section 7: Normal and Secondary Test Subject New Package Questions ............ 154

BIBLIOGRAPHY ............................................................................... 192

viii

LIST OF TABLES

Table 1 — Age and Corresponding Average Grip Strength (Spirduso, 1995) ................. 15
Table 2 — Universal Design Principles (Betty, Rose, et a1, 1997) .................................. 23
Table 3 — Human Variability Categories (Tilley, 1993) ................................................. 28
Table 4 — Color Associated with Descriptive Adjectives (Burgess, 1986) ..................... 34
Table 5 — Population Percentile Conversion (Tilley, 1993) ........................................... 73
Table 6 - ZPrinter 310 System General Specifications (Zcorporation, 2003) ............... 76
Table 7 — Package Part Legend ..................................................................................... 102

ix

LIST OF FIGURES

Figure 1 — Structure of the Human Ear ............................................................................. 9
Figure 2 — Structure of the Human Eye .......................................................................... 10
Figure 3 — Structure of the Human Hand ........................................................................ 13
Figure 4 — Structure of the Human Brain ........................................................................ 17
Figure 5 - Height Frequency Distribution Curve (Tilley, 1993) .................................... 27
Figure 6 — Grip as it Relates to Distance (Salvendy, 1997) ............................................ 31
Figure 7 - High Torque (Tilley, 1993) ........................................................................... 32
Figure 8 — Rotary Knobs (Tilley, 1993) .......................................................................... 32
Figure 9 — Triggers and Tool Grip (Tilley, 1993) ........................................................... 33
Figure 10 - Non Child-Resistant Daily Dose Organizer ................................................ 36
Figure 11 — Child-Resistant Daily Multi-dose Organizer ............................................... 37
Figure 12 — Child-Resistant Daily Dose Organizer ........................................................ 37
Figure 13 — Sketch of Package ........................................................................................ 39
Figure 14 — Initial Package Drawing .............................................................................. 40
Figure 15 — Package Model ............................................................................................ 41
Figure 16 - Organizer Dispenser Package Final Illustration .......................................... 43
Figure 17 - Rhino 3.0 Rendering of Package Prototype ................................................ 45
Figure 18 — Rhino 3.0 Rendering of Package Prototype Open ....................................... 45
Figure 19 — Rhino 3.0 Rendering of Package Prototype Gears ...................................... 46
Figure 20 - Rhino 3.0 Rendering of Package Prototype Bottom View .......................... 46
Figure 21 — Nonworking Prototype ................................................................................ 47

Figure 22 — Model Creation ............................................................................................ 50

Figure 23 — Manufactured Package Parts ....................................................................... 51
Figure 24 — Unassembled Prototype Parts ...................................................................... 51
Figure 25 — Prototype Assembly ..................................................................................... 52
Figure 26 — Assembled Prototype ................................................................................... 53
Figure 27 - Normal and Secondary Test Subject: Physical Condition ........................... 60

Figure 28 — Normal and Secondary Test Subject: Physical Condition per Age Range.. 61
Figure 29 — Secondary Test Subject: Arthritis, Stroke, and other Physical Condition... 62

Figure 30 — Normal and Secondary Test Subject: The Package Method of Use was Easy
to Understand .......................................................................................................... 63

Figure 31 — Normal and Secondary Test Subject: The Feel of the Handle is
Comfortable ............................................................................................................ 64

Figure 32 — Normal and Secondary Test Subject: The Distance of the Two Buttons is
Adequate ................................................................................................................. 65

Figure 33 — Normal and Secondary Test Subject: The Distance of the Two Buttons is
Comfortable for Individuals with Decreased Physical Hand Dexterity, Such as

Gripping or Pinching Strength ............................................................. 66
Figure 34 — Normal and Secondary Test Subject: This Package Will Aid in Medication

Compliance for Both Individuals with or without Physical Hand Dexterity .......... 67
Figure 35 — Normal and Secondary Test Subject: If Manufactured, I have a desire to

Own and to use this Package .................................................................................. 68
Figure 36 — ZPrinter 310 System .................................................................................... 76
Figure 37 — Solid Oral Organizer Sketch ........................................................................ 78
Figure 38 — Solid Oral Organizer Sketch 2 ..................................................................... 79
Figure 39 — Solid Oral Organizer Sketch 3 ..................................................................... 80
Figure 40 — Solid Oral Organizer Sketch 4 ..................................................................... 81
Figure 41 — Solid Oral Organizer/Dispenser Sketch ....................................................... 82

xi

Figure 42 — Solid Oral Organizer/Dispenser Sketch 2 .................................................... 83

Figure 43 — Solid Oral Organizer/Dispenser Gear and Ratchet Sketch .......................... 83
Figure 44 — Solid Oral Organizer/Dispenser Gear and Ratchet Sketch 2 ....................... 84
Figure 45 — Solid Oral Organizer/Dispenser Gear and Ratchet Sketch 3 ....................... 85
Figure 46 — Top View of Package .................................................................................. 87
Figure 47 — Top View of Package with Closure and Cover Removed ........................... 87
Figure 48 — Top Cross-Section View of Package Second Closing and Advancement
Mechanism .............................................................................................................. 88
Figure 49 — Top View of Package Second Housing ....................................................... 88
Figure 50 — Top View of Package without Closure and Cover ...................................... 89
Figure 51 — Top Cross-Sectional View of Package through Circular Wall of First
Housing ................................................................................................................... 89
Figure 52 - Top View of Package First Housing ........................................................... 90
Figure 53 — Top View of Package Lock Release, Trigger, Ratchet, and Break in
Relation to One Another ......................................................................................... 91
Figure 54 — Top View of Package First Gear and Second Gear in Relation to One
Another ................................................................................................................... 91
Figure 55 -— Top View of Package Sliding Door ............................................................. 91
Figure 56 - Top View of Package Wheel Cap ............................................................... 92
Figure 57 — Bottom View of Package Wheel Cap .......................................................... 92
Figure 58 - Top View of Package Wheel Cap 2 ............................................................ 92
Figure 59 — Top View of Child-Resistant Closure ......................................................... 92
Figure 60 — Top View of Package Clear Cover .............................................................. 93
Figure 61 — Bottom View of Package Clear Cover ........................................................ 93
Figure 62 — Top Perspective Exploded View of Package ............................................... 94

xii

Figure 63 — Bottom Perspective Exploded View of Package ......................................... 95

Figure 64 — Top Perspective View of Package ............................................................... 96
Figure 65 — Top Perspective View of Package with Separated Clear Cover, First
Housing, and Second Housing ................................................................................ 96
Figure 66 — Bottom Perspective View of Package ......................................................... 97
Figure 67 — Back View of Package ................................................................................. 97
Figure 68 — Front View of Package ................................................................................ 97
Figure 69 — Front View of Package with Exposed Sliding Door Chamber .................... 97
Figure 70 — Side Cross-Sectional View of Package Wheel Cap .................................... 98
Figure 71 — Bottom Perspective View of Wheel Cap ..................................................... 98
Figure 72 — Top Perspective View of Wheel Cap .......................................................... 98
Figure 73 — Side Cross-Sectional View of Package Child-Resistant Closure ................ 98

Figure 74 — Top View of Package Inner Workings which Illustrate how to Advance
Rotary Wheel with Lock Release in Unlocked Position ......................................... 99

Figure 75 — Top View of Package Inner Workings which Illustrate how to Advance
Rotary Wheel by Pulling Trigger ............................................................................ 99

Figure 76 —- Top View of Package Inner Workings which Illustrate how to Access the
Contents with Rotary Wheel in a Resting Position ............................................... 100

Figure 77 — Top View of Package which Illustrates How to Refill Package by
Disengaging Child-Resistant Closure ................................................................... 101

Figure 78 — Top View of Package which Illustrates How to Refill Package by
Removing Closure and Cover ............................................................................... 101

Figure 79 — Secondary Test Subject: Arthritis, Stroke, and Other Physical

Condition ............................................................................................................... 114
Figure 80 — Secondary Test Subject: Male Arthritis Condition per Age Range .......... 115
Figure 81 — Secondary Test Subject: Male Stroke Condition per Age Range .............. 116
Figure 82 — Secondary Test Subject: Male Other Condition per Age Range ............... 117

xiii

Figure 83 — Secondary Test Subject: Male Multiple Physical Conditions per Age

Range .................................................................................................................... 117
Figure 84 — Secondary Test Subject: Female Arthritis Physical Condition per Age

Range .................................................................................................................... 118
Figure 85 — Secondary Test Subject: Female Stroke Physical Condition per Age

Range .................................................................................................................... 119
Figure 86 — Secondary Test Subject: Female Other Physical Condition per Age

Range .................................................................................................................... 120
Figure 87 — Secondary Test Subject: Female Multiple Conditions per Age Range ..... 121

Figure 88 -— Normal and Secondary Test Subject: Solid Oral Medication and Vitamin
Supplement Combination Consumption - Age Range 21 — 45 ...................... 122

Figure 89 — Normal and Secondary Test Subject: Solid Oral Medication and Vitamin
Supplement Combination Consumption - Age Range 46 — 60 ...................... 123

Figure 90 — Normal and Secondary Test Subject: Solid Oral Medication and Vitamin
Supplement Combination Consumption - Age Range 60 — 77 ...................... 124

Figure 91 — Normal and Secondary Test Subject: Solid Oral Medication and Vitamin
Supplement Combination Consumption - Age Range 77+ ........................... 125

Figure 92 — Normal and Secondary Test Subject: Solid Oral Daily Medication Use -
Age Range 21 — 45 ................................................................................................ 126

Figure 93 — Normal and Secondary Test Subject: Solid Oral Daily Medication Use -
Age Range 46 — 60 ................................................................................................ 127

Figure 94 — Normal and Secondary Test Subject: Solid Oral Daily Medication Use -
Age Range 60 — 77 ................................................................................................ 128

Figure 95 - Normal and Secondary Test Subject: Solid Oral Daily Medication Use -
Age Range 77+ ..................................................................................................... 129

Figure 96 — Normal and Secondary Test Subject: Solid Oral Daily Vitamin
Supplemental Consumption - Age Range 21 — 45 ................................................ 130

Figure 97 -— Normal and Secondary Test Subject: Solid Oral Daily Vitamin
Supplemental Consumption - Age Range 46 — 6O ................................................ 131

Figure 98 — Normal and Secondary Test Subject: Solid Oral Daily Vitamin
Supplemental Consumption - Age Range 60 — 77 ................................................ 132

xiv

Figure 99 — Normal and Secondary Test Subject: Solid Oral Daily Vitamin
Supplemental Consumption - Age Range 77+ ..................................................... 133

Figure 100 — Normal and Secondary Test Subject: Solid Oral Daily Medication/Vitamin
Supplement Package Use - Age Range 21 — 45 .................................................... 134

Figure 101 — Normal and Secondary Test Subject: Solid Oral Daily Medication/Vitamin
Supplement Package Use - Age Range 46 - 60 .................................................... 135

Figure 102 — Normal and Secondary Test Subject: Solid Oral Daily Medication/Vitamin
Supplement Package Use - Age Range 60 — 77 .................................................... 136

Figure 103 — Normal and Secondary Test Subject: Solid Oral Daily Medication/Vitamin
Supplement Package Use - Age Range 77+ ......................................................... 137

Figure 104 - Normal and Secondary Test Subject: Solid Oral Daily Medication/Vitamin
Supplement Combination Package Use - Age Range 21 — 45 .............................. 138

Figure 105 — Normal and Secondary Test Subject: Solid Oral Daily Medication/Vitamin
Supplement Combination Package Use - Age Range 46 — 60 .............................. 139

Figure 106 — Normal and Secondary Test Subject: Solid Oral Daily MedicationNitamin
Supplement Combination Package Use - Age Range 60 — 77 .............................. 140

Figure 107 — Normal and Secondary Test Subject: Solid Oral Daily MedicationNitamin
Supplement Combination Package Use - Age Range 77+ ................................... 141

Figure 108 — Normal and Secondary Test Subject: Child-Resistant Package Ease of Use
-Age Range 21 —45 ............................................................................................. 142

Figure 109 - Normal and Secondary Test Subject: Child-Resistant Package Ease of Use
- Age Range 46 — 60 ............................................................................................. 143

Figure 110 — Normal and Secondary Test Subject: Child-Resistant Package Ease of Use
- Age Range 60 — 77 ............................................................................................. 144

Figure 111 — Normal and Secondary Test Subject: Child-Resistant Package Ease of Use
- Age Range 77+ ................................................................................................... 145

Figure 112 — Normal and Secondary Test Subject: Pill Organizer Use - Age Range
21 — 45 ................................................................................................................... 146

Figure 113 — Normal and Secondary Test Subject: Pill Organizer Use - Age Range
46 — 60 ................................................................................................................... 147

XV

Figure 114 — Normal and Secondary Test Subject: Pill Organizer Use - Age Range
60 — 77 ................................................................................................................... 148

Figure 115 - Normal and Secondary Test Subject: Pill Organizer Use - Age Range
77+ ........................................................................................................................ 149

Figure 116 - Normal and Secondary Test Subject: Pill Organizer/Dispenser
Use/Preference - Age Range 21 — 45 .................................................................... 150

Figure 117 — Normal and Secondary Test Subject: Pill Organizer/Dispenser
Use/Preference - Age Range 46 — 60 .................................................................... 151

Figure 118 - Normal and Secondary Test Subject: Pill Organizer/Dispenser
Use/Preference - Age Range 60 — 77 .................................................................... 152

Figure 119 - Normal and Secondary Test Subject: Pill Organizer/Dispenser
Use/Preference - Age Range 77+ .......................................................................... 153

Figure 120 - Normal and Secondary Test Subject: Package Method of Use was Easy to
Understand - Age Range 21 - 45 .......................................................................... 154

Figure 121 — Normal and Secondary Test Subject: Package Method of Use was Easy to
Understand - Age Range 46 — 60 .......................................................................... 155

Figure 122 — Normal and Secondary Test Subject: Package Method of Use was Easy to
Understand - Age Range 60 -— 77 .......................................................................... 156

Figure 123 — Normal and Secondary Test Subject: Package Method of Use was Easy to
Understand - Age Range 77+ ................................................................................ 157

Figure 124 — Normal and Secondary Test Subject: The Feel of the Handle is
Comfortable - Age Range 21 — 45 ........................................................................ 158

Figure 125 — Normal and Secondary Test Subject: The Feel of the Handle is
Comfortable - Age Range 46 — 60 ........................................................................ 159

Figure 126 — Normal and Secondary Test Subject: The Feel of the Handle is
Comfortable - Age Range 60 — 77 ........................................................................ 160

Figure 127 — Normal and Secondary Test Subject: The Feel of the Handle is
Comfortable - Age Range 77+ .............................................................................. 161

Figure 128 — Normal and Secondary Test Subject: The Distance of the Two Buttons is
Adequate - Age Range 21 — 45 ............................................................................. 162

xvi

Figure 129 - Normal and Secondary Test Subject: The Distance of the Two Buttons is
Adequate - Age Range 46 — 6O ............................................................................. 163

Figure 130 — Normal and Secondary Test Subject: The Distance of the Two Buttons is
Adequate - Age Range 60 - 77 ............................................................................. 164

Figure 131 - Normal and Secondary Test Subject: The Distance of the Two Buttons is
Adequate - Age Range 77+ ................................................................................... 165

Figure 132 —- Normal and Secondary Test Subject: The Distance of the Buttons is
Comfortable for Individuals with Decreased Physical Hand Dexterity, Such as
Gripping and Pinching Strength - Age Range 21 — 45 ......................................... 167

Figure 133 - Normal and Secondary Test Subject: The Distance of the Buttons is
Comfortable for Individuals with Decreased Physical Hand Dexterity, Such as
Gripping and Pinching Strength - Age Range 46 — 60 ......................................... 169

Figure 134 — Normal and Secondary Test Subject: The Distance of the Buttons is
Comfortable for Individuals with Decreased Physical Hand Dexterity, Such as
Gripping and Pinching Strength - Age Range 60 - 77 ......................................... 171

Figure 135 — Normal and Secondary Test Subject: The Distance of the Buttons is
Comfortable for Individuals with Decreased Physical Hand Dexterity, Such as
Gripping and Pinching Strength - Age Range 77+ ............................................... 173

Figure 136 — Normal and Secondary Test Subject: I Would Feel Comfort in Knowing
that the Dispenser I Use is Child-Resistant - Age Range 21 — 45 ........................ 175

Figure 137 — Normal and Secondary Test Subject: I Would Feel Comfort in Knowing
that the Dispenser I Use is Child-Resistant - Age Range 46 — 60 ........................ 177

Figure 138 — Normal and Secondary Test Subject: I Would Feel Comfort in Knowing
that the Dispenser I Use is Child-Resistant - Age Range 60 — 77 ........................ 179

Figure 139 -— Normal and Secondary Test Subject: I Would Feel Comfort in Knowing
that the Dispenser I Use is Child-Resistant - Age Range 77+ .............................. 180

Figure 140 — Normal and Secondary Test Subject: This Package will Aid in Medication
Compliance for Both Individuals with or Without Decreased Physical Hand
Dexterity - Age Range 21 — 45 ............................................................................. 182

Figure 141 — Normal and Secondary Test Subject: This Package will Aid in Medication

Compliance for Both Individuals with or Without Decreased Physical Hand
Dexterity - Age Range 46 — 60 ............................................................................. 184

xvii

Figure 142 — Normal and Secondary Test Subject: This Package will Aid in Medication
Compliance for Both Individuals with or Without Decreased Physical Hand
Dexterity - Age Range 60 — 77 ............................................................................. 185

Figure 143 — Normal and Secondary Test Subject: This Package will Aid in Medication
Compliance for Both Individuals with or Without Decreased Physical Hand
Dexterity - Age Range 77+ ................................................................................... 186

Figure 144 — Normal and Secondary Test Subject: If Manufactured, I Have a Desire to
Own and Use This Package - Age Range 21 — 45 ................................................ 187

Figure 145 - Normal and Secondary Test Subject: If Manufactured, I Have a Desire to
Own and Use This Package - Age Range 46 — 60 ................................................ 188

Figure 146 - Normal and Secondary Test Subject: If Manufactured, I Have a Desire to
Own and Use This Package - Age Range 60 — 77 ................................................ 189

Figure 147 - Normal and Secondary Test Subject: If Manufactured, I Have a Desire to
Own and Use This Package - Age Range 77+ ...................................................... 190

xviii

Introduction

Two major functions of packaging are utility and communication. Package
utility includes package usefulness and ease of use, whereas package communication
provides information that leads to the purchase of a product, and promotes safe and
economical use of a package and/or the packaged product. These functions are
important for all products. When a package is difficult to open, problems ranging from
frustration to severe injury and medication noncompliance can occur.

The utility and communication functions influence medication compliance.
Medication compliance is the act of taking the correct dose of the correct medication at
the correct time. Medicines can only help if they are taken as prescribed.

Problems with package utility and communication happen because most
packages are designed for people with normal physical and psychological abilities,
including people with normal hand dexterity, adequate vision, and no serious physical
disabilities.

Injuries, frustration, and medication noncompliance can happen to anyone,
especially within the aging population. Because modern medicine, science, and
technology, in this country, has brought the majority of infectious disease epidemics
under control, people born in this country can expect to live about 78 years (Arias &
Smith, 2003). Life expectancy in the United States has risen by 18.5 years since 1930,
when it was about 59 years (Minino & Smith, 2001). This increased life expectancy will
consequently result in a greater portion of our population being inflicted with

degenerative diseases, such as arthritis, osteoporosis, diabetes, hypertension, heart

disease, incontinence and physical frailty. These conditions are becoming increasingly
our largest healthcare problem (Spirduso, 1995).

As the population ages a rise in medication noncompliance will increase. Studies
have shown that medication non-compliance causes 125,000 deaths annually in the US.
(Smith, 1989). It leads to 10 to 25 percent of hospital and nursing home admissions, and
is becoming an international epidemic. It is, in the words of The New York Times, the
world’s “other drug problem” (Zuger, 1998).

Legislation specific to packaging that protects children from accidental
poisonings and protects all users from product tampering, is administered by the Food
and Drug "Administration (FDA). Label legibility is also regulated by the FDA to help
people read and understand the provided information.

Legislation has improved the usability of certain products for individuals with
disabilities, but does not include package design. Public Law 104-104, The
Telecommunications Act of 1996, requires telecommunication manufacturers and
service providers to ensure that equipment is designed, developed, and fabricated to be
accessible to, and usable by, individuals with disabilities, if this is readily achievable.
Existing legislation, which aids people with disabilities, may lead to legislation that
promotes consumer-friendly packaging.

Many companies use consumer friendly packaging because people associate
consumer-fiiendly packaging with product quality. These companies design
product/package systems to keep loyal customers and to attract more consumers

(McMath & Forbes, 1998).

The purpose of the project discussed in this thesis was to design a child-
resistant, solid oral, pharmaceutical/over-the—counter/vitamin supplemental
organizer/dispenser (CRMOD) package that is universally designed. For a package to
be considered “universally designed”, it must be useful for healthy adults, as well as for
adults with abilities that are affected by the effects of aging and disability.

Applying universal design to a package requires the careful consideration of
human factors and ergonomics. Ergonomics, generally defined as the study of human
beings and their interaction with products, environments, and equipment in performing
tasks and activities, can be used to improve the utility and communication of packages,
making packages easier to use and understand. Ergonomics, the design of products to be
user fiiendly, can enable a person to encode (read), comprehend, and comply with the
instructions given (Bix, 2001 and Rousseau et a1, 1998).

Based on the above information, the objective of the project was to design and
evaluate a CRMOD package. Testing was performed to determine if the techniques for
using the new package are easy to learn and understand.

The research presented in this document also includes specific human and
package interactions that occur while using pharmaceutical/over—the-counter (OTC)
medication/dietary supplement packaging, with an emphasis towards the abilities of the
elderly population.

The fundamental hypothesis of this research was that, by manipulating specific
packaging components of a CRMOD package, a more consumer-fiiendly and child-

resistant package will result.

Chapter 1: Literature Review

Why Design a Consumer-Friendly and Child-Resistant Pharmaceutical/OTC
Organizer/Dispenser Package?

Designing a consumer-fiiendly and child-resistant solid oral pharmaceutical
multi-compartmental organizer and dispenser (CRMOD) package that is universal, as
well as reusable, will be beneficial. Although many people with decreased hand
dexterity experience difficulty when using packages, there are many people with normal
hand dexterity that also experience difficulty with packages (Ibberson, 2000).

Difficulties with package opening, closing, and reading and comprehending
instructions, are common. These problems occur because many packages are designed
for people with normal physical strength and eyesight.

Consumer frustration, injuries, and death have occurred as a result of difficulties

with package use. When people can’t open a package they become fi'ustrated.

This frustration often results in people not taking their medications, or they take

measures of opening the package into their own hands. Very often, people will

try to open the package using inappropriate tools, such as opening packages
using knives. These tools often result in accidents. It has been reported that
packaging related accidents involving knives account for 6% of all the reported

accidents (Ibberson, 2000).

Many people of all ages are taking dietary supplements for overall health, as
well as to supplement their exercise regime. According to Mediamark Research, Inc.,
10.8% of the 193,462,000 adults studied used calcium supplements, with garlic and
multi-vitamins following at around 7.5% (Mediamark Research, 1997). Because the

population is growing, and because studies continue to indicate the benefits of taking

vitamins, it is predicted that more people will be using them.

Why Design a Consumer-Friendly and Child-Resistant PharmaceuticaVOTC
Organizer/Dispenser Package for the Aging Population ?

Medication Noncompliance
As the population ages, the effects of medication noncompliance are expected to

affect more people. Medication compliance, which is the taking of the correct
medication, in the correct quantity, at the correct time, is a major problem in US.
healthcare today. This is evident from the number of people who are hospitalized or die
each year because of medication noncompliance, and is especially severe in the elderly
population. Liability and insurance costs, which result in the loss of money to the
economy, are also affected by medication noncompliance.

Almost 50% of the 1.8 billion prescription medications, dispensed annually, are

not taken correctly by patients. One researcher has estimated that only one-third

of all patients take all their prescribed medicine, while one-third take only some,
and an astonishing one-third take none at all. In Oregon, nearly 10% of all
hospital admissions have been reported to be the result of pharmaceutical
noncompliance. The U. S. Chamber of Commerce estimated, in 1984, that
medication noncompliance caused a $13 — 15 billion loss to the economy due to
increased use of medical resources, unnecessary physician visits, therapeutic

failure and prolonged illness (Smith, 1989 and Lockhart, 2002).

Health conditions that must be treated with medications become more common
when people age. These health conditions, when coupled with the side effects of some
medications, can negatively affect the body. This phenomenon is the focus of
Pharmacokinetics. Pharmacokinetics is the study of the action of drugs in the body,
including the processes of absorption, transformation, distribution to tissues, duration of

action and elimination.

Disability
A person is considered to have a disability if he or she has difficulty performing

certain functions (seeing, hearing, talking, walking, climbing stairs, and lifting and

carrying), or has difficulty performing activities of daily living, or has difficulty with
certain social roles (doing school work for children, working at a job or around the
house for adults). A person who is unable to do one or more activities or uses an
assistive device to get around, or who needs assistance from another person to perform
basic activities, is considered to have a severe disability (U .S. Department of
Commerce, 1997).

Many people do not admit, or believe, they have a disability. For those that do
admit to having a disability, about in 1 in 5 Americans ages 5 and over, 47.9% of the
total population, have some form of disability, and 1 in 10 have a severe disability
(United States Department of Commerce, 1997). And, with the population aging, as
well as the likelihood of disability increasing with age, the growth in the number of
people with disabilities can be expected to accelerate in the coming decades.

About 9 million people of all ages have disabilities so severe that they require

personal assistance. Disability occurs with any age, sex, or race. Even among

children aged 6 to 14, for instance, 1 in 8 had some form of disability.

Nevertheless, the likelihood of having a disability increases with age — half of

seniors aged 65 and older have a disability (U .8. Census Bureau, 2002).

The health of many older Americans is threatened by chronic conditions.
Statistics for the most prevalent chronic conditions, since 1995, state that 88% of
Americans aged 65 and over have at least one chronic health condition, such as arthritis,

hypertension, heart disease, or cancer (King & Buchner, 1998).

Child Safety
Even though special packaging is now required for use with 30 household

substances by the Consumer Product Safety Commission (CPSC), child poisonings still

occur. Public Law 91 -601, the Poison Prevention Packaging Act, which was passed by

Congress in 1970, seeks to protect small children by requiring that dangerous household
substances be sold in special packages that are child-resistant (CPSC, 2003).

The CPSC estimates over 900 children’s lives have been saved since the law
was passed (CPSC, 2003). However, there are still thousands of serious accidental
poisonings occm'ring every year in the United States. About 30 fatalities from poisoning
of children under the age of five occur each year (Bush, 2003). Some of these accidents
occur because the child-resistant feature has been disabled by an adult to avoid
difficulties with child-resistant features, or because of accidental failure to enable the
child-resistant feature.

Child poisonings are expected to increase proportionately with the aging
population growth. In the United States, approximately five to six percent of
grandchildren, and ten percent of grandparents, live in grandparent-grandchild
households at any given time (Pebley & Rudkin, 1999). Many poisonings occur when
children visiting grandparents explore the medicine cabinet or grandmother’s purse.

Physical and Cognitive Changes Associated with Aging
Apart from life, aging is one of the few experiences shared by every human.

Although all people age, they do so in different ways and at different rates. Some
people live longer and have a higher quality of life than others. Gerontology is the study
of these differences, their causes, and the factors that amplify or attenuate them
(Spirduso, 1995).

Chronological age is the amount of time between birth and date of observation.
The physical dimension of age and meaning of time depend on the biological,

psychological, and social significance attached to it. Biological processes that occur in

youth are thought of as developmental, whereas time-related changes that lead to
disability and dysfunction are thought of as aging, or senescence (Spirduso 1995).

Aging is a process, or group of processes, occurring in living organisms that,
with the passage of time, lead to a loss of adaptability, functional impairment, and
eventually death.

Aging is classified as normal (primary or universal) aging and secondary aging.
Normal aging is associated with the loss of vision, hearing, strength, and cognition,
which are independent of disease. Secondary aging is accelerated aging that occurs as a
result of disease or environmental factors. Hearing, vision, and cognition are important
for communication, whereas physical strength is important for physical ability
(Spirduso, 1995).

Age-Related Changes in Audition (Hearing)
Hearing is crucial for humans, since most of the time we relate to each other

through verbal communication. Hearing loss is thought by many to be the most
devastating handicap of all, frequently resulting in withdrawal from interactions with
society and meaningful people such as family and friends. Subtle changes in hearing
usually begin in the 40s and progress gradually with age. It has been estimated that 55
percent of those over age 65 have some hearing loss, while by age 80, 66 percent have
serious hearing problems (Saxon, 1987).

Changes in audition occur with primary and secondary aging. Specific aging
changes in audition include the pinna losing some of its original flexibility. The pinna
also becomes larger and wider. Hairs in the external ear canal become stiffer. Decreased
flexibility of the tympanic membrane reduces the acoustic reflex, which is a protective

mechanism that contracts in response to loud noises (Saxon, 1987). (Figure 1)

   
   
  
 
 

Semicircular canals
Bone

Malleus

Pinna

Nerve
to brain
Sensory cells
‘ ‘ of the cochlea
Eustachian tube
External
auditory
canal

Figure 1 — Structure of the Human Ear

Presbycusis, the loss of hair cells in the cochlea, eventually produces hearing
impairment. This age related auditory loss occurs gradually, with the perception of high
frequency sounds usually being affected first. Later changes may involve middle and
low frequency ranges as well. In our culture, men tend to show hearing loss earlier than
women. If the speculation that more males than females have been exposed to high
level occupational noise is correct, sex differences in auditory loss could be primarily
due to environmental exposure, rather than to inherent sex-related differences. Speech
intelligibility is especially affected (Saxon, 1987).

An important bit of information is that those that have been affected by hearing
loss are reluctant to admit it. Therefore, oral instructions might be only partially
understood. Loss of this fimction increases the importance of label reading
comprehension.

Hearing changes can also affect the ability to hear a package noise, such as the

snap of a child-resistant lock being engaged.

Age-Related Changes in Vision
Aging adults have a decrease in visual acuity. This is because several changes

occur in the eye as a result of aging. (Figure 2)

Sclerotic coat

 
 
 
   
 
    
 
 

Choroid coat

Vitreous humor

  

Foveal pit
............. X

Cornea /\

Aqueous humor

Iris / \ ‘

Optic nerve

    

/

 

Blind spot

To nose

Figure 2 — Structure of the Human Eye

With advancing age, the cornea flattens somewhat, causing reduced refractive
ability. There is also a tendency toward corneal astigmatism due to subtle changes in the
shape of the cornea in the older eye. With time, a grayish-yellow ring tends to form
along the iris-sclera border (arcus senilus). Another age-related change in the iris is that
some fading of the color occurs, which results in eyes of older individuals not appearing
as lustrous as the eyes of younger individuals (Saxon, 1987).

The pupil size decreases with age. It is estimated that reduced pupil size and the
yellowing of the lens, with age, may result in a 60-year-old individual’s retina receiving

only approximately 30 percent as much light as the retina of a 20-year-old. Lens

10

changes with age have several effects on the efficiency of the visual system (Saxon,
1987)

The vitreous humor becomes less gel-like and more liquid-like with age. It also
becomes less transparent and causes light rays to scatter as they pass throughout the
vitreous humor to the retina causing blurred vision and opacities known as “floaters”,
which are loose cells casting shadows on the retina (Saxon, 1987).

The retina, referred to as an extension of the brain, has decreased blood flow
with age, as well as some loss of rods and cones. Light and dark adaptation decrease
with age. There is a higher threshold of sensitivity with age so that more light is needed
to adequately stimulate visual receptors. Visual threshold refers to the minimum amount
of light that will stimulate the rods or cones and trigger nerve impulses to the brain
(Saxon,1987)

The final visual change of significance for visual coping and adaptive behaviors
is a decrease in visual acuity (sharpness of vision). Visual acuity decreases with age.
Visual acuity is poor in children, improves in young adulthood, and begins to decline
gradually at about age 40. Changes in the lens, pupil size, composition of the vitreous
humor and ability to shift from near vision to far vision serve to decrease the sharpness
of visual images as we grow older (Visual Expert, 2002).

The decrease in visual acuity with age presents a need for better legibility, which
begins with the sizes and fonts used. To effectively notice and decode (read) printed
label information, consumers must physically perceive the text using their vision

(Rousseu, 1998 and Bix, 2001).

11

A ge-Related Changes in Grip Strength
Bone and muscle mass develop together during youth, and decline together

during aging (Spirduso, 1995). Beginning in the mid-20s, the rate of bone formation
begins to fail to keep pace with resorption, in which bone loss occurs. By age 90 some
women have lost 90% of their cancellous bone mass, whereas for men it is usually 10%
to 25%. This loss of bone is related to hormonal changes that occur as the body ages
(Spirduso, 1995).

Bones are linked together at articulations (joints) by ligaments, tendons, and
connective tissue. The attachment is also supported by the muscles that cross the joint.
A smooth, rubbery covering of hyaline cartilage covers the ends of the bones so they
can move with relatively little friction. This cartilage also absorbs shock when the two
bones are pressed together by muscular action using external forces. Joint flexibility is
described by the extent to which the linked bones can be moved before being stopped

by bony structures or tight ligaments (Salvendy, 1997). (Figure 3)

l2

 

f ‘ .e'
Ulnar nerve ' /
Transverse
:' / o

Pisiforrn Radial artery
Primary auditory
rt
co ex Median nerve

 

 

 

 

 

 

Tendon

Figure 3 — Structure of the Human Hand

Adults lose a significant amount of flexibility as they age, and these losses can
be measured when individuals, themselves, actively move the limb through the range of
motion or when the clinician passively moves the limb (Spirduso, 1995).

Exercise contributes significantly to joint stability and flexibility. Resistive
exercises enhance the tensile strength of tendons and ligaments, and flexibility exercises

maintain suppleness of tendons, ligaments, and muscles, thus promoting full range of

13

joint motion. Stretching exercises are important for middle-aged and older people
(Spirduso, 1995).

Chronic diseases, such as osteoporosis and osteoarthritis, cause significant
disability in the elderly. These diseases affect nearly 80% of adults over the age of 65
(roughly 6 million people) (Spriduso, 1995). Nearly all older adults suffer from some
degree of osteoarthritis, and this may limit hand strength and the ability to manipulate
fingers. Several researchers have found that older adults have difficulty opening
containers with child-resistant closures (Fisk & Rogers, 1997).

It has been found that grip strength is related to aging. A study was done to find
changes in grip strength on 847 males within ages 20 to 100 using a grip dynamometer,
which measures the maximum amount of strength that an individual can produce in
gripping. This study showed that grip strength loss with age differed greatly among the
population. Most people lost strength, but some did not. Some older subjects lost less
strength over a 10-year period than did the middle aged and young subjects, while 29%
of the middle aged subjects, and 15% of the older subjects, lost no strength at all.
According to Table 1, the average grip strength for a 50 year old is 100 kg and begins to
decline from there. An average of 95 kg is the grip strength for a 60 year-old, whereas
average grip strength of 85 kg is had by a 70 year-old. A grip strength average for an

80-year old is 70 kg (Spirduso, 1995).

14

Table l — Age and Corresponding Average Grip Strength (Spirduso, 1995)

Age, Years A Gri S
lbs

20 47
30 48

4O 47
50 45
60 44
70 39
80 33

 

A ge-Related Changes in Cognition
Understanding the cognition involved in using products and packages is

important to prevent an increase of the effects of noncompliance, such as hospitalization
and death. This emphasis on cognition, as it relates to safety, can eliminate difficulties
experienced while using child-resistant packaging (Better Packages, 2004).

Memory impairments affect more than one-third of men and women ages 85 and
older (Federal Interagency Forum on Aging-Related Statistics, 2000).

In order to accurately adhere to a complicated regimen, an older adult has to

comprehend instructions on each medication, use working memory to integrate

those instructions into a daily plan, use long-term memory to remember what the
plan is, and, finally, engage prospective memory to remember to take the

medication (Park & Schwarz, 2000).

There are mechanisms that have been hypothesized to account for age
differences in cognition, which include the speed at which information is processed,
memory, reasoning performance, inhibitory function, and spatial visualization. Each of
these mechanisms can be thought of as a type of cognitive or processing resource, and

one author has suggested that combinations of these mechanisms may be an even better

estimate of cognitive resource than any single measure (Park & Schwarz, 2000).

15

Salthouse suggests that the fundamental mechanism that accounts for age-
related differences in performance is the decreased speed of performing mental
operations. He collected a large amount of evidence that indicates nearly all age-related
differences on almost any kind of cognitive task, ranging fi'om memory to reasoning,
can be explained by the rate at which the individual makes quick comparisons on
perceptual speed tasks (Park & Schwarz, 2000).

Perceptual speed tasks are simple paper-and-pencil measurements that require

the individual make rapid perceptual same-different judgments about pairs of

digit or letter strings or two similar symbols. Speed of processing is measured by
the number of comparisons correctly made in a fixed period of time. The
important mechanism responsible for the relationship between speed of
processing and cognition is the limited time mechanism, which suggests that the
time to perform later operations is greatly restricted. Older adults’ performance
will differ substantially from younger adults on tasks such as working memory,

recall, and reasoning slowing even though these tasks do not necessarily appear
to have a speed component (Park & Schwarz, 2000).

What is Cognition?

Cognition can be thought of in terms of fimctions of the brain, such as memory,
association, comparison, abstract reasoning (verbal and quantitative), spatial ability and
manipulation, and synthesis. The process of cognitive attention (mental energy),
working memory, information processing speed, psychomotor ability, and perception
support the cognitive functions and processes interact to enable individuals to make
decisions and behave intelligently. Tests have been developed with the hope of
assessing the application of brain functions to psychological and social function.

However, much is yet to be learned (Spirduso, 1995).

16

Mechanisms of Cognition and the Brain
Mechanisms of cognition are controlled by the brain. The brain, as illustrated in

Figure 4, has three major regions: the hindbrain, the midbrain, and the forebrain (Neath
& Suprenant, 2003).

Motor cortex

    
 
 
 

Central sulcus

Partial-temporal-occipital
association cortex

. Al
' 7 II 21'.- ’
u .‘I': .I.." J ‘
- - - -. . . .
5233-" . 0'3: p51“: ' . 1” ° '
.- .e . . can 1 o
‘ I ‘. - .'- : c at 'w
. a. , n'
M‘ l ‘ ’ . .. ,.

  
    
   
 

Prefrontal 4. ,

association ," ‘ Primary visual

cortex //‘ $34., cortex
0&1 ,

Temporal lobe 049g.

/ [a ,
\\=—”\€ Preoccipital notch
.. . ‘8'

Prim auditory Sylvian fissure
corteiry Cerebellum

Figure 4 — Structure of the Human Brain

The hindbrain, including the cerebellum, is responsible for the coordination of
movement and regulates basic body functions. The midbrain, which is located between
the hindbrain and the forebrain, is involved in reflexive responses. Also included in the
midbrain are dopamine-releasing neurons that control smooth motor-skill movement.
The forebrain is associated with complex thought and cognition (Neath & Suprenant,
2003)

The thalamus, the hypothalamus, and the limbic system are part of the forebrain.

The thalamus can be thought of as a sensory relay station. Structures that surround the

17

thalamus are the amygdale, the septum, and the hippocampus. The amygdale is an
evaluation system that contributes to feelings of fear and anger. Damage to the
amygdale impairs the evaluation of stimuli. The hippocampus has been identified as an
important structure for memory (Neath & Suprenant, 2003).

The frontal lobe is responsible for motor control and contains an area called the
motor cortex, which controls the precision of motor control. Frontal lobes are important
for a number of memory functions (Neath & Suprenant, 2003).

Memory is not the function of any single structure, but is a part of local
operations carried out in all cortical areas where the information to be remembered is
processed and perceived. Memory, a mechanism that is part of cognition, enables the
use, or retrieval, of information that was previously decoded and processed. Memory
can be divided into five major categories. These are procedural memory, the perceptual
representational system, primary procedural memory, which includes short-term
memory and working memory, episodic memory and semantic memory (long-term
memory).

Procedural memory is responsible for learning associative relations, simple
relations, simple conditioning, and motor and cognitive skills.

Primary procedural memory is for the learning and retention of a wide
assortment of motor and cognitive skills, such as playing the piano, driving a car,
solving a jigsaw puzzle, and reading. These abilities have a large automatic component
associated with them, and typically do not involve the conscious recollection of the

initial learning episode (Park & Schwarz, 2000).

18

Short-term memory is a memory store that holds information for a short period
of time. Information within this store is forgotten over time if the information is not
rehearsed (Neath & Suprenant, 2003).

Working memory is the ability to hold some information in mind while you’re
doing something else (Hambrick, 2003). Working memory capacity, the extent to which
a person can control and sustain attention during interference and distraction, varies
among individuals.

The speed of performing mental operations, such as those involved in working
memory, affects free and cued recall. Free recall is a task in which individuals recall a
list of items in any order. Cued recall is when individuals recall previously presented
items with a cue.

Cognitive Processes in Using Products/Packages
Using products or packages involves a decision process. The decision process

involves three phases:
0 Assembling all possible information about alternatives
0 Analyzing the possible courses of action and outcomes

0 Selecting the best alternative

In the case of using pharmaceutical/OTC packages, the decision process also
includes the awareness that a medication needs to be taken.

Along with the awareness that a medication should be consumed, it is also
important the medication being taken is the correct medication that is taken in the

correct amount and at correct time. Poor short-term memories, especially in people with

19

diseases that alter memory, impaired visual acuity, and reduced physical strength,
negatively affect medication compliance.
Cognition is an important aspect of package use that can improve medication
compliance.
“Visual acuity and cognition are the most important human functions of opening
a senior friendly and child-resistant package. People need to get away from
designing packages that require strength because the elderly tend to have
deceased dexterity. Designing a package that requires the cognitive abilities to

open a package using two or three steps is beneficial for keeping young children
out of packages.” (Fuller, 2002)

Cognitive Change Theories

Lifespan development consists of dual processes of gains and losses. Two of the
theories used to explain the effects of normal aging on memory are the disuse view and
the multiple systems view.

The disuse view of age-related declines has been termed the “use it or lose it”
view. The analogy is to muscles, where exercise increases performance, and lack of
exercise induces atrophy, or physical and psychological degeneration and weakening.

The multiple systems view states that memory can be broken down into a
number of functionally different memory systems, including episodic, semantic, and
procedural memory, with episodic memory being the last system to develop and the first
system to be impaired (Neath & Suprenant, 2003).

Age differences will be small or nonexistent for tasks that require the use of
semantic memory, but are greatly affected for tasks that use episodic memory. It has

been suggested that the “process” is affected rather than the system.

20

Problems with Cognitive Claims
Although there is statistical evidence for physical aliments, such as for the

proportion of elderly people with arthritis, it is not as easy to provide definitive
evidence for decreases in cognition, even though there is a great deal of scientific
evidence indicating that mental processes become less efficient during the process of
aging. This is because adults compensate for losses by using acquired knowledge. There
is strong evidence that indicates growth of knowledge and experience helps to
compensate for decreases in cognition, making decreases in cognition more difficult to
measure (Hambrick, 2003).

Stereotyping, preconceived or oversimplified generalizations about an entire
group of people without regard for individual differences, has an impact on
performance. Even when stereotypes are positive they can lead to discrimination.
Stereotypes make cognition difficult to study because people tend to live up to how
others perceive them. Stereotypes suggest that elderly individuals are slower at
performing many tasks and have poorer memories than when they were younger.

Prevention of Age-Related Cognitive Declines
Exercise plays a large role in health. Exercise has been proposed to directly affect major

areas of brain function:
0 cerebrovascular function
0 cerebral neurotransmitter balance
0 cerebral neurotransmitter function
a neurotransmitter balance
0 neurotransmitter function

0 neuroendocrine tone

21

Exercise maintains cerebralvascular integrity by increasing oxygen transport,
which reduces hypoxia (lack of oxygen) in active brain regions. Cerebral hypoxia is
common among older people in poor health. Oxygen is essential for the metabolism of
glucose, the brain’s fuel, and it also is a critical ingredient for the metabolism of
norepinephrine, and serotonin (Spirduso, 1995). With regular exercise, these types of
diseases can be postponed or prevented.

Guidelines for Consumer-Friendly Package Design

Utility and communication functions of packaging play a large role in case, and
hindrance, of product use. Difficulty with using a package can occur with people of all
physical and psychological abilities. To increase consumer-fiiendliness with products
and packages it is important that utility and communication functions, based on
physiological and psychological abilities, be understood and implemented. Universal
Design and the science of human factors engineering are ways to improve these
functions.

Universal Design
Universal Design includes seven principles that may be applied to guide the

design process and to educate both designers and consumers about the characteristics of
more usable products and environments, but not all of the principles may be relevant to
all designs. The seven principles that are depicted in Table 2 include equitable use,
flexibility in use, simple and intuitive use, perceptual information, tolerance of error,

low physical effort, as well as size and space for approach and use.

22

Table 2 — Universal Design Principles (Betty, Rose, et a1, 1997)

 

Universal Design Principles

    
   

 

  
 

 

 

Principle Title Description
Number
1 Equitable Use The design is useful and marketable to
people with diverse abilities
2 Flexibility in Use The design accommodates a wide
range of individual preferences and
abilities
3 Simple and Intuitive Use Use of the design is easy to

understand, regardless of the user’s
experience, knowledge, language
skills, or current concentration level

 

4 Perceptual Information The design communicates necessary
information effectively to the user,
regardless of ambient conditions or the
user’s sensory abilities

 

5 Tolerance for Error The design minimizes hazards and the
adverse consequences of accidental or
unintended actions

 

6 Low Physical Effort The design can be used efficiently and
comfortably and with a minimum of
fatigue

 

7 Size and Space for Approach Appropriate size and space is provided
and Use for approach, reach, manipulation, and
use regardless of user’s body size,
posture, or mobility

 

 

 

 

 

The principles of Universal Design address only universally usable design,
while the practice of design involves more than consideration for usability. Designers
must also incorporate other considerations such as economics, engineering, cultural,
gender, and environmental concerns in their design processes. The Universal Design
principles offer designers guidance to better integrate features that meet the needs of as
many users as possible (Rose, Betty, et al, 1997).

Human Factors
The science of human factors, synonymous with ergonomics, is a collection of

human properties and interactions with products, environments, and equipment in

23

performing tasks and activities. The term “human factor” encompasses both
physiological and psychological, and covers most factors affecting human performance
(Salvendy, 1997).

Throughout history, human factors knowledge has been implemented to make
equipment easier to use. Applying human factors to packaging and products has and
will continue to make packaging and products more consumer-fiiendly.

Human factors, first used in the 19405, provides information that should be used
when designing for humans. However, before the identifying title of human factors
existed, much work in this area had already been accomplished. Charles Babbage, in his
1932 book “Economy of Machinery and Manufacture”, described methods for making
worker’s jobs easier and more economical, which was based on the principle of
“division of labor” earlier formulated by Adam Smith in his “Wealth of Nations”, in
1776 (Burgess, 1986).

Human factors has largely proven its worth in military and space flight
applications. It has been making a major impact in civilian‘ and industrial applications.
Ergonomics is cost effective and improves compatibility of the machines, products, and
packages with their users, which can be seen in reduced human error and increased
productivity (Burgess, 1986).

History of Human Factors
The science of human factors is also known as human engineering. The US.

Navy used the term human factors; whereas the other branches of the US. military used
the term human engineering. During World War 11, new and complex war machines
were required, and the concept that machines, not personnel, win wars, gave way to

efficient man-machine relationships. Before long, many scientific disciplines were

24

being consulted. These disciplines included psychology, engineering, antlrropometry,
and physiology. The Department of Defense issued human engineering standards for the
design of military equipment for the Army and human factors information for the Air
Force and the Navy. This work was based on 90% of the adult males acceptable for
certain segments of military service (Tilley, 1993).

By the 19605, a systematic gathering of data was ongoing, and the US.
Department of Health, Education, and Welfare published “Weight, Height, and Selected
Body Dimensions of Adults”. In the 19705, the Society of Automotive Engineers made
a very useful survey of children, from two-month-old infants to eighteen-year-old
youths. In the 19805, the elderly were measured when it became evident that they were
becoming a large segment of the population (Tilley, 1993).

In 1990, the Americans with Disabilities Act (ADA) became law and prohibited
discrimination on the basis of disability. The act provides rules of accessibility and
protection for wheelchair occupants, for the blind and visually impaired, and for the
deaf and hearing impaired.

In the Telecommunications Act of 1996, Section 255 required
telecommunications products and services to be accessible to people with disabilities,
requiring the design of products to be compatible with adaptive equipment used by
people with disabilities, where readily achievable.

Human Factors Implementations
The field known as human factors recognizes that there are capabilities and

limitations of the human organism (HO), which include sensory limitations, information

processing limitations, and limitations of the effector subsystem (Burgess, 1986). These

25

capabilities and limitations directly affect the ability of a HO to perform specific tasks,
such as the use of prescription or OTC medication packages.

Sensory limitations that include the auditory modality (hearing mechanism), the
visual modality (sight mechanism), and other sensory limitations, such as touch and
smell, have an influence on a person’s ability to make decisions. Cognitive information
processing skills used in making decisions include expectancies, objectivity, memory
and data processing, emotionalism, boredom and sensitivity to stress (Burgess, 1986).

Capability and limitations of the effector subsystem are affected by body
measurements, a human factor study area known as anthropometry. Anthropometric
data is useful for designing a machine, or product, based on body size characteristics, in
which there are bio-mechanical limitations (strength, response-speed, and tracking
capability) and sensory limitation in space perception (Burgess, 1986).

There are many measurement tools involved in gathering data of the body size
and its components. Because of this, anthropometry is time-consuming and expensive.
The most complete and reliable information has been prepared by the military forces,
while civilian data is not complete.

Large samplings, such as 2000 to 4000 men and women, are needed because a
large sample produces greater accuracy. Several types of measurements are taken and
then plotted on a graph, with the measurements on the horizontal axis increasing
towards the right from the zero point. The frequency of occurrences is plotted vertically
on the axis, increasing toward the top from the zero point. A smooth curve averaging a
dimension will appear bell-shaped (Gaussian or normal distribution curve). In this case,

the mean, median, and mode coincide. The mean is the arithmetical average of values,

26

the median is the middle number of the values, and the mode is the most commonly
occurring value and the highest point on the curve. Figure 5 is a typical frequency

distribution curve representing height.

    
 

10,000
9,000
.5
5 s 000
E r
2
3 7,000
(I)
N
g 6,000
..
.c: 5.000
.29
D
:1: 4,000
‘4—4
0 3,000
>.
8
a, 2,000
8-
g 1,000
u-
0
59 6061 64656667 707172 737475 777879

1 percentile 50 percentile 99 percentile

Height Measurement, in

Figure 5 — Height Frequency Distribution Curve (Tilley, 1993)

Problems with Human Factors
Because of the variability of people, it is often a problem when designers choose

a “single percentile model”, where it is assumed that many people can fit into the
chosen percentile. Using the 5th or 95th percentile does not represent actual users.
Because of this, a range of percentiles, such as 5th to 95th percentiles, would fit more of

the actual users.

27

At times a smooth curve averaging a particular height dimension will not be a
normal distribution curve. If weight or flesh measurements (for example, hip width,
buttock depth, or abdominal depth) are plotted, the resulting curve is not symmetrical;
the peak of the curve is off center. This curve is referred to as a skewed curve, in which
case the mean, median, and mode do not coincide. Data from one dimension do not
necessarily correlate with those of other dimensions. For instance, a small woman may
have a small or large hip width or buttock depth, and so on (Tilley, 1993).

No two people are exactly alike, including identical twins, and this diversity
poses a problem for the designer. According to Tilley, there are roughly three categories

of human variability. (Table 3)

Table 3 — Human Variability Categories (Tilley, 1993)

 

  
      

Definition

  

Sizes change during adult life. Some changes are due to
aging and/or nutrition; others are caused by movement
and/or the environment. The face and body are usually
asymmetrical. This may be the reason some people do not
like photographs of themselves; they are accustomed to
seeing themselves in the mirror, which reverses the image.
Inter-individual There are big differences due to sex, ethnic and racial
membership. Differences include skin color, eye and hair
color, body proportions, and other features.

Secular variability Changes occur from generation to generation for various
reasons. However, the pace of these changes is relatively
slow.

 

 

 

 

 

 

Accurate human factors data for the last decade is difficult to assess because of
the immigration of many shorter people. It has been said that the US. population “has
the most diverse ethnic and racial mix of any country in the world.” However, it does

not represent the world population.

28

Japanese women that are smaller than the Japanese 15th percentile would not
even be included in a U. S. study, because the 1St percentile Japanese woman is
2.3” (58 mm) shorter than the 1"t percentile American woman. American and

Canadian farmers are taller than the 99th percentile U. S. male. This particular

group’s 95th percentile stature of 75. 6” (1920 mm) coincides with the 99th

percentile U. S. population stature (Tilley, 1993).

It is difficult to accommodate the entire world population, so excluding a
percentage of very small and very tall people is necessary.

It is not customary to design for everyone. The few at either end of the normal
curve may be so extreme that an encompassing design could become too large, or too
expensive, to produce. The military chose to exclude 5% at the small end and 5% at the
large end, thus accommodating 90% of the measured population in the Military
Standards. The 5% value is called the 5th percentile, and the 95% value is called the 95’h
percentile. Any other percentile values may be chosen by using a population percentile
conversion table for estimating various percentiles (Tilley, 1993). (Appendix 1)

Measurements can also vary depending on posture. Height varies between a
straight or rigid posture as much as 0.2” to 0.8” (5 to 20 mm). There is a loss in height
due to relaxing into a slumped position (Tilley, 1993). These anthropometrical values
are based on data from Human Scale 1/2/3, 1974; NASA, 1978; and US. Department of
Health, Education, and Welfare, 1966 and 1979. Infant to youth 18 years of age was
adapted from SAE, 1975 and 1977 (Tilley, 1993).

Chronological age serves only as an index for biological, psychological, and
sociological changes that occur, and older adults are not a homogeneous population.

There are much greater individual differences among the elderly and aging populations,

beginning at age 60. These differences increase with age, especially with people over

29

age 80. Data, for a distinct population of the elderly, exists for people of ages 65 to 79,
but is not available for people 80 to 90 years of age.

Making use of guidelines and standards, including the Safe Medical Devices Act
of 1990, as well as human factors, and ANSI standards, can help. Developing
participant groups for usability testing is also recommended, and can be accomplished
by looking to community support groups. Taking a systems approach to design requires
the designer to look beyond the design of the equipment to the system in which it must
function, the environment.

Human Factors - Economy of motion
Five kinds of motion are listed below in order of increasing effort, exertion, and

time of operation:

Finger

Finger and wrist.

Finger, wrist, and forearm.

Finger, wrist, forearm, and upper arm
Finger, wrist, forearm, upper arm, and body

9:59P!“

Because hand strength is reduced 16% — 40% by age 65, a result of arthritis and
normal loss of strength, it is important that package use should require minimal
strength. Gripping mechanisms, such as triggers and handle shapes and sizes, are
important to reduce needed strength. In theory, human factors data can be consulted to
find the range of strength, as well as motion, which is most comfortable for the desired
percentage user (Tilley, 1993).

Grip strength, as a function of grip opening and hand anthropometry, is an
important concern when opening packages. Figure 6 shows grip strength capacity as a
function of the separation distance of grip opening. This figure indicates that there is a

very narrow range of grip openings that can maximize grip strength. If the grip opening

30

deviates from this ideal range, by as little as an inch, the grip strength is dramatically
reduced. This trend is also due to a length-strength relationship with the forearm

muscles.

 

 

 

kg lb
54 120
45 100
§
:6: 36 80
9.
E0 27 6O —
S 5th percentile male
E 18 40 — _
a 50th percentrle female
2 9 20 — ,
I I I 5th percentile female
0 00 1 2 3 4 5 in
O 25 51 76 101 127 mm

Grip axis opening
(0) Grip strength

Figure 6 — Grip as it Relates to Distance (Salvendy, 1997)

The use of a larger diameter continuous thread closure, as well as the use of less
turns and torque, can be helpful. These components can be compared to high torque and
rotary knob specifications. A high-torque knob is a rugged valve knob with a palm grip
or five-finger grasp of 1.5” (22 mm) min — 1” (25.4 mm) max. Finger notches help. A
Skirt length of 0.5” (13 mm) min - 1” (25.4 mm) max should be used. Torque may

range from 0 to 5.2 oz (f) — TN (0.037 N - m). (Figures 7 and 8)

31

Palm grip or five finger grasp
.1 1.5"MIN - 3"MAX_l

38mm - 76mm '

 

 

 

 

 

 

Finger nOtCheS help —/ 0511va _ lnMAX lnMN
12.7MM - 25.4 ‘ ' ‘ fif
Torque: 201b (f)-IN (2.3 N m)

Figure 7 — High Torque (Tilley, 1993)

 

 

Finger tip grip/continuous rotation
sized to accomodate differently abled

Is—Possible marking

 

 

 

 

Possible skirtfi‘ WPossible pointer
Knurling medium torque:
1" t40 1.85"D
Smooth low torque /
Serrated higher torque/ 0fi"0 5.. MIN 1"MAX A ‘
13mm- 2.54 W

 

 

 

Torque: 0 to 5.2 oz (f)-IN (0.037 N - m)
Knob separation: 2" (51mm) MIN

Figure 8 — Rotary Knobs (Tilley, 1993)
For packages with handles, infOrmation used for triggers and hand tools are
useful. Dimensions of the hand grip can vary depending on the force to be exerted as
long as the minimums are preserved. There are many variations are possible that can be

used for trigger design. (Figure 9)

32

 

       
  

Many variationspossible

0.2" Tr vel
l 5mm

 

 

 

 

 

m
0.25”MIN 0.5"MAX
6mm 13mm

Figure 9 — Triggers and Tool Grip (Tilley, 1993)

 

Communication
Pictorial symbols become important when language barriers, or simply not

reading instructions, prevent effective communication. According to Kenneth Fuller,
more women read directions than men do. A simple and intuitive package design may
include informative icons, which are visual representations of objects, scenes, or people,
printed on a surface. Icons can be used to cue recall and may provide a quick reference
on how to use a package (Fuller, 2002).

Symbols must be easily read and interpreted as a common language, and
promote common understanding. Pictorial symbols represent common meanings within
a variety of cultural backgrounds. However, a symbol alone may not be sufficient for
symbol understanding. Pictorial symbols may carry vivid emotional, cultural, national
and religious meanings. Standardization of some pictorial symbols has already been
adopted for international use. Standard International ski trail markings, for example,
have been in use for a number of years (Burgess, 1986).

Because people don’t generally take their medications in perfectly lighted
conditions, it is important to use an effective contrast of colors to enable differentiation

of drug identification and warning differentiation. There is evidence that suggests

33

symbol recognition decreases with age because of changes in visual acuity. The benefit
of symbols can only happen if they are seen and understood (Burgess, 1986).

Color is an important factor in communication. Color-coded symbols are an
effective way to improve the comprehension of what is being said. It was found that
identification and reading time was slowed down by not matching words with colors
(Burgess, 1986). Warren (1974) studied the association between word meanings and
color and found that they are strongly associated. For example, when asked to identify
the color associated with various descriptive adjectives, strong associations were

indicated (Burgess, 1986). (Table 4)

Table 4 — Color Associated with Descriptive Adjectives (Burgess, 1986)

 

 
   

Descriptive Stop Minor Active Clear
Adjective Alarm Standby Enable

Critical Manual

Failure On

Major Run

disable

 

 

 

 

 

 

 

Restricting the number of colors for instructions and warnings is useful in
communicating smoothly, and without confusion.

Arrangement of instructions and pertinent identification, as well as warning
information, is important because the HO has been known to be easily confused, and to
miss significant signals. Less confusion and increased reliability result when convenient

and reliable reading configurations are presented.

34

Chapter 2: Design and Development Process

Special packaging, packaging that is child-resistant, has prevented many child
poisonings. Recent amendments to packaging, under the direction of the CPSC, require
child-resistant packaging to be easier to use for the elderly and the handicapped.

Implementing ease of entry into a child-resistant pill organizer package for the
elderly and the handicapped, as well as for people without compromised abilities, would
make it easier for people to store their dietary supplements and solid oral medication in
organizers and increase medication compliance, as well as to prevent child poisonings.
The use of a pill organizer is beneficial if several medications are used daily. Filling a
pillbox takes a few extra moments, once a week, but reduces the chance of medication
errors (Wong & Norman, 1987).

Inspiration
The idea for the design of a child-resistant solid oral pharmaceutical/OTC

medication/vitamin supplemental (CRMOD) package came from existing solid oral
medication/dietary supplement organizer packages. These packages come in many
forms, but usually have several compartments in which to organize medications and
vitamin supplements for daily, or several times a day, doses. Some are child-resistant
and some are not child-resistant.

Although these packages have increased medication compliance, there are
shortcomings. These shortcomings include hazardous substances being removed from
child-resistant containers and placed into organizers that are not child-resistant. (Figure

10) Accidental child poisonings have resulted.

35

    

Figure 10 — Non Child-Resistant Daily Dose Organizer

Two child-resistant organizers are shown in Figures 11 and 12. To access the
contents of the child-resistant organizer shown in Figure 11, the user must first press
and hold a button located at the upper right hand side of the package, unlocking the
sliding covers of the compartments, and then slide the covers open to access the
compartments and their contents. To access the contents of the child-resistant organizer
shown in Figure 12, the user must also first press and hold a button on the side of the
organizer to unlock the flip top covers of the individual compartments. Once unlocked,
the flip top covers may be opened. If the user finds these difficult to use, frustration and

medication noncompliance can occur.

36

 

Figure 12 — Child-Resistant Daily Dose Organizer

37

After review of the available packages, including an analysis of shortcomings, it
was decided that a CRMOD package should be designed that is easy to use by the
elderly and individuals with disabilities and can also be used by people without reduced
hand dexterity or disabilities.

Package Design Development
The most important objective of the package design process was to improve

package utility, while providing child-resistance. Both parameters were studied
simultaneously to enable a “child-resistant and consumer-friendly” package concept to
emerge.

For this package, both utility and child-resistant features were used that required
cognitive skills involving two or three steps to use the package. In theory, children ages
five and younger do not have the cognitive skills to perform two or more sequential
actions to access the contents of a package. This makes the two or three steps for
package opening beneficial in keeping children under the age of five out of packages.

It is often painfill for people with arthritis to extend and to bend their fingers.
Hence, the two or more actions used to open a child-resistant package must not require
users to bend their fingers significantly, or require much strength to perform these
actions. It makes sense that by using a large distance between two buttons, which must
to be activated sequentially to open a package, would also keep small children out of
packages because the hand span of a small child is much smaller than that of an adult.

A package that would require the use of only one hand, instead of two, will be
beneficial to people who have had strokes. Severe strokes can debilitate parts of the

body, possibly preventing the use of a hand.

38

Because many people lead busy lives, the size of the organizer is also important.
The organizer would need to be easy to transport. This feature, along with one hand
operation, would be an added convenience.

Therefore, the goal was to design a convenient child-resistant package that
would dispense a daily dose of medication/dietary supplements that would also reduce
the amount of work for the user in hand dexterity and finger bending, and would fit into
a purse or a bag.

Sketches
With the previously discussed factors in mind, the package design process

began. After much thought and sketching, the new package idea was born. (Figure 13
and Appendix 3)
I. In click unlocks, advances and dispenses.

2nd clock lock

2. C lick and hold unlocks, advances, dispenses

Let go - locks. and advances.

 

Ath ance

 
   

Closure stays on.
' Unlocks when in 'open" position.
'9 Locks when in closed position.

1 Continuous closure lock.
i Push and tum. l I April, 2003

Figure 13 — Sketch of Package

39

Package Design Illustration
The sketch of the package, which contained most of the working mechanisms,

was computer generated, using Adobe Illustrator 6.0. At this stage, the working
mechanisms, which were the two buttons used for the child-resistant feature, the eight-
compartrnent “cam-wheel” that would hold the daily dosage, the advancing gears to

advance the cam-wheel, and dispensing and refilling features were fine-tuned. (Figure

 

 

14)
Cam Whiiel Loci:
A __
@ E
09“ DO‘kI’ l‘.
Slide Door—9 gTTgI-iffv T ‘T @ i 0 4.30..
Gear ,
Gear
©
III II
Advance -—> _

 

 

 

 

 

 

7.00” I

Figure 14 — Initial Package Drawing

40

Model
The package design illustration was then used to proceed to the next stage, the

production of a model. This model was created to see if the mechanisms worked, as

well as for ergonomic testing. (Figure 15)

\4
\
‘\
.1)

b

k ,‘Q'Ol

 

Figure 15 — Package Model

Hunt Foam Board, 3/ 16” thickness, which is a sofi, three-layered board with a
black foam layer in the center and black outer layers of paper, was used to make the
package parts. Package parts were cut fiom the foam board using an X-ACTO® knife.
The package parts were then assembled using machine screws, hex and lock nuts, nylon

fasteners, springs, and stainless steel sheet metal.

41

After evaluation of the assembled model, it was decided that the package needed
ergonomic and mechanical changes. Ergonomically, the package was difficult to hold
the way it was intended to be held because there was no handle. Using human factors
information, based on 5th percentile, as well as for the reduced abilities of people with
arthritis, a handle was added. A grip diameter of 4.25” was implemented, which is
larger than the optimal 0.875” — 1.25” handle grip diameter, with the intention to
prevent children under the age of five from accessing the package contents. Children
that are five years of age have a hand grip diameter of .60” — .85” (Tilley, 1993).

Mechanically, the gears would not mesh together to enable the gears to turn
simultaneously, and the ratchet that advanced the gears would not move the gears as
intended. Gears with 48 teeth, a 1.25” outer diameter and inner diameter of 1.125”,
were made. A ratchet, with a curved tip on one side and straight on the other side,
replaced the previous ratchet to enable a smoother transition of the ratchet across the

gear teeth.

42

Once the non-working model was finished, the original Adobe Illustrator 6.0

drawing was updated to reflect these changes. (Figure 16)

  
     

Slide Door ——>

5 3/8'

 

Advance —>

 

L 61X)"

I

“1

Figure 16 — Organizer Dispenser Package Final Illustration

43

Nonworking Prototype
After the non-working model was complete, the next step in the package

development began, which was to make a prototype. Using Rhino 3.0, a three-
dimensional (3D) drafting program that is used by many animators and industrial
designers, the package was drawn as a 3D image. This was accomplished by importing
the updated Adobe Illustrator 6.0 file directly into Rhino 3.0. From the imported
drawing, individual two-dimensional (2D) drawings were extruded into 3D images.

Boolean unions, differences, and intersections were also used during this
process. A Boolean union occurs when two or more 3D images, that were created
separately, are overlapped and combined into a single image. The newly formed image
takes the form of the two images put together. A Boolean difference occurs when two or
more 3D images, created separately, are overlapped and combined into one image. The
resulting image takes the form of one of the first image minus the second image, leaving
a void in the first image where the second image once was. A Boolean intersection is
where two or more 3D images, created separately, are overlapped and combined into
one image. The resulting image subtracts all parts of the images except for the parts of
the images that overlap.

After the parts were drawn, clearance between objects was added to allow for
part movement, such as the gear and button openings that rotate on posts. This clearance
measured approximately 0.0625”. The clearance was added to accommodate the
thickness of the epoxy coatings, which is added to strengthen the manufactured package

parts used in rapid prototyping. (Figures 17, 18, 19, and 20)

44

 

 

Figure 17 - Rhino 3.0 Rendering of Package Prototype

 

Figure 18 — Rhino 3.0 Rendering of Package Prototype Open

45

 

 

Figure 19 - Rhino 3.0 Rendering of Package Prototype Gears

 

Figure 20 — Rhino 3.0 Rendering of Package Prototype Bottom View

46

Once the package part drawings were complete, they were saved and exported
individually into a stereolithography, .S'I'L, binary format and then electronically sent to
the University of Michigan’s 3D Media Center in Ann Arbor, Michigan, to be printed,
or manufactured. The 3D non-working prototype parts were produced on the ZPrinter
310 System using ZPIOZ, a plaster based powder. (Appendix 2)

The first printing resulted in a non-working prototype that needed more
clearance between parts, and structural changes to some of the parts. The second
printing of this package produced prototype parts that could be constructed successfirlly,
after some modification, performed with sandpaper. Two copies of this package were

produced; one for testing and another for display. (Figure 21)

 

Figure 21 — Nonworking Prototype

47

New Package Features
This package was designed to enable consumer-friendly access to medications

or vitamin supplements for people with decreased hand dexterity, such as arthritis,
while preventing small children from accessing the contents of the package.

How Package Works
Package dimensions are 7.0” x 4.3” x 2.0” (length, width, height). The package

features eight “daily” compartments, each having the capacity to hold several different
sized solid oral medications and vitamins. The compartments are pie shaped, forming
the cam-wheel, which rotates in a counter-clockwise motion. This motion is manually
controlled by the user, who simply grasps the handle of the package, with either hand,
and pushes first the top button to unlock the locked gear, with an index finger or chin
(Gleason, 2003) and while still holding down the top button, compresses the bottom
button to advance the unlocked gear, which advances the cam wheel one step to the next
day.

To access contents of the compartments, as well as to prevent the contents from
spilling out of the dispensing opening, a slide door that is not child-resistant, and which
is manually opened or closed by the user, is provided.

Eight compartments, instead of seven, are provided for mechanical symmetry,
child-resistance, and as a reminder to refill the compartments for the upcoming seven
days. Because the sliding door is not child-resistant, an empty compartment should be
kept in front of the sliding door when the package is not in use.

To refill the package, a typical continuous thread child-resistant closure that is
imbedded into a transparent cover to protect the contents of the compartments is

removed. The closure is simply pushed down and turned counter-clockwise. This

48

unlocks the closure, which can then be pulled up and removed to expose the
compartments. Once refilling is complete, the clear lid and closure is simply placed on
top of the exposed compartments, pushed down, and twisted clockwise to return to the
original locked position (Appendix 4).

Child-Resistant Feature
Two actions must take place to access the contents of this pill organizer. The

lock on the advance wheel must be disengaged before the wheel can be cycled into
position for the next day. This child-resistant feature would make it difficult for a child
aged five and younger to access the contents of the package. A child would need the
cognitive abilities to determine that the top button, which locks and unlocks the
package, and the bottom button, which advances the cam-wheel, must be operated
sequentially to access the package contents. Also, because the handle grip distance
between the two buttons, that are required to unlock and advance the compartments, is
greater than the handle grip capacity of a toddler or young child’s hand, .60” - .85”
(Tilley, 1993), small children will be prevented from unlocking and rotating the cam-
wheel to get to the next day’s medication dose.

Intangibilities
The package itself, when seen in the store, will have the feeling of a beautiful,

sterile, package that is fun to watch when it is being advanced to the next day. A
commercial version of the unit should be transparent to enable viewing of the
components inside, such as the gears and levers involved in advancing the wheel to the
next day. However, this may inspire small children to try to use the package.

Amber was chosen as the color of the transparent outer plastic of the package to

block ultraviolet rays that could cause the medication inside the package to decompose.

49

Chapter 3: Materials and Methods

Consumer input during the design process is important for the success of any
product. Improvements in graphics and prototyping technology have enabled the
realistic depiction of how a product might look when manufactured (Fisk & Rogers,
1997).

Package Prototype
A prototype can be a mock-up, model or actual working version of a

technological device or process. Prototypes are used to generate engineering

information that will help design or perfect the final product/process (UMaine, 2004).
Before a prototype was made for testing purposes, a model was created to

determine if the working mechanisms would work, and to evaluate the package

ergonomics. (Figure 22)

 

Figure 22 — Model Creation

50

Changes were made to the drawing that corrected the now apparent problems of

the model. Then, the prototype parts were printed. (Figure 23)

 

Figure 23 — Manufactured Package Part5

After completion, the parts were prepared for prototype assembly. (Figure 24)

 

Figure 24 — Unassembled Prototype Parts

51

To prepare the parts for assembly a very fine sand paper was used to smooth
rough surfaces and to further increase clearance between parts, such as the top and
bottom cover of the package, so that they fit together nicely.

When all parts were prepared, the prototype was assembled. (Figures 25 and 26)

 

Figure 25 - Prototype Assembly

52

 

Figure 26 — Assembled Prototype

Because the new package requires the use of flexible materials for some of the
working parts, the prototype does not work like a finished version of the package
would. Therefore, the prototype is considered non-working. This non-working
prototype was created to determine package usage comfort, such as holding the package
in your hand, as well as button placement. Consumer understanding of how the package
works was also tested.

Rapid Prototyping Technology
Rapid prototyping, a new technology that prints 3D objects quickly and

accurately, was used to manufacture the non-working prototype of this package.
The technology of rapid prototyping is one method used for creating 3D objects
in three dimensions. Just as you can currently print out a drawing in 2D, rapid

prototyping allows you to print an object. It works by taking a computer model and

53

slicing it into thousands of very thin layers. Each of these layers can be laid down, one
at a time, by a device printing with plastic (which is often called “Fused-Deposition
Modeling” (FDM) or with thin layers of paper, metal foil, ceramic, or various other
materials. Over time, each layer builds up until you have a completed model (Z
Corporation, 2003). The ZPrinter 310 System printed copies of each part of the new

package. (Appendix 2)

54

Chapter 4: Test Procedure

To prove that the package would provide people an easier way to adhere to their
medication regime, the package was tested on people, including individuals with
disabilities. The test procedure presented in this chapter consisted of subject orientation
and the collection of subj ect-related information.

Subject Orientation
Testing was performed in various locations, representing realistic conditions

where people might actually take their medications. Subjects were tested in homes,
retirement centers, physician offices and group gatherings because medications are
rarely taken under optimal, and controlled, conditions.

Before testing began, subjects were provided with an overview of the package,
the reason for the development of the package, and the components of the package that
enable the package to be easier to use.

“This is a non-working prototype of a newly developed automatic pill
organizer/dispenser that was developed to make medication taking easier for
everyone, including people with arthritis, and other physical conditions that
cause using a pill organizer to be difiicult to use. This is only a prototype. The
actual manufactured package will be made of a transparent plastic and will be
lighter than the prototype. If you choose to participate in this study you will be
asked information regarding your age, sex, physical condition affecting your
hands, if any, as well as questions about medication packaging that is commonly
used. I am also asking for your opinion about comfort and learning aspects of
the new package, such, as comfort of the distance between the two buttons that
are required to be pressed simultaneously in order to access the next dose, as
well as the comfort of holding the package using the package handle. Your
opinion of package ease of learning and understanding how to use the package is
also needed. If there are any questions or need for clarification during any part
of this test, please ask. If there are any suggestions or concerns about this
package they are also welcome. This information will be anonymous; your name
will not be recorded on the questionnaire. This testing will take no longer than
20 minutes.”

55

To protect the test subjects’ rights, subjects were asked to review and sign a
written consent form (IRB # 03-830; expiration date October 13, 2004). Before testing
began, subjects signed the form, signifying acceptance of the invitation to participate.
To further protect the subjects’ rights, test subjects also signed a media consent form,
signifying their acceptance to allow images, such as photographs or video, to be taken
of them during testing.

For the protection of the newly developed package, the Michigan State
University Office of Intellectual Property required test subjects to sign a confidential
disclosure agreement, in which each receiving party agrees neither to use the
confidential information for any purpose other than for evaluation nor to provide the
confidential information to any third party other than a signatory to this agreement for a
period of five (5) years upon the receipt of the confidential information (Appendix 5).
The Michigan State University invention disclosure identification number for this
package is MSU 4.1-662-ID03-070.

Collection of Subject-Related Information
After the subject signed the consent and confidentiality forms, a closed end

questionnaire was used to record general subj ect-related information, health and
medication daily consumption, medication packaging, and new package questions.
(Appendix 6)

The general subject-related information section asked about test subject age. An
appropriate age range was required to be chosen by the test subjects to categorize the
age of the test subject. The gender (sex) information required test subjects to choose one

of two options; male or female.

56

The health and solid oral daily consumption section asked for information about
physical condition, and daily medication/vitamin intake. The physical condition section
asked test subjects to choose one of two options; normal or secondary. Normal meant
test subjects without disease related conditions affecting hand dexterity. Secondary
meant disease related conditions affecting hand dexterity. If secondary, test subjects
were asked about the physical condition that was affecting their hand dexterity, such as
arthritis, stroke, or other. If the test subject checked the “arthritis” box, they would then
check the appropriate box for arthritis type, such as osteoarthritis, rheumatoid arthritis,
or other. If test subjects checked the “stroke” box, they would then check the
appropriate box for stroke severity, such as minor or major paralysis. If the test subject
checked the “other” box, they would then write the condition on the provided line.
(Appendix 7)

Once health information was collected, test subjects were then asked to provide
information about the type of daily medication/vitamins they take, if any. Each test
subject was asked to check the appropriate “medication/vitamin” boxes. The box
options were solid (such as pills and tablets) or liquid (such as elixirs and spirits). Each
test subject was also asked to provide information on how many medications/vitamins
they take on a daily basis. (Appendix 7)

The packaging section asked questions about types of containers their
medications/vitamins come in, the ease of use of the packages, whether they use pill
organizers/dispensers, as well as pill organizer/dispenser preference. (Appendix 7)

The package questions gave test subjects an opportunity to provide their

opinions of the newly designed package. Test subjects were asked about the ease of

57

understanding how to use the package, if the feel of the package handle was
comfortable (successful ergonomic design of handle), if the distance of the two buttons
was at an adequate distance apart (the distance between the two buttons was
comfortable for use with two fingers on one hand), if the two buttons were at a
comfortable distance for those with decreased hand dexterity (such as gripping and
pinch strength), comfort in knowing the pill organizer/dispenser they use is child-
resistant, aid in medication compliance of those with and without hand dexterity
problems, and desire of owning and using the newly designed package, if the package is
manufactured.

The purpose for asking normal subjects to answer “if the two buttons were at an
adequate distance for those with decreased hand dexterity (such as gripping and pinch
strength)” was to provide insight into how the normal subjects in this study viewed the
abilities of individuals with secondary physical conditions.

The term “medication compliance” was described to each test subject to help
them to give their opinions on how this package may increase medication compliance.

The questions were set up as a Likert scale. A Likert scale includes the
“statements” in the left-hand column of the chart, and the opinions the test subjects
were provided with to choose from were located on the top row of the chart. This was
provided to enable test subjects easy response to the “statements”, which were strongly
agree, agree, neither agree or disagree, disagree, and strongly disagree. Test subjects
would simply check the box the best described their opinion of a statement (Trochim,

2002). (Appendix 7) All answers to the questions are unsupported opinions; not facts.

58

Chapter 5: Results and Discussion

To determine if the package does make it easier for people to take their
medication, specific components of this nonworking package prototype were tested on
100 test subjects, 50 normal and 50 secondary. Results were not tested for statistical
significance, but provided useful information that will aid in the research and
development of improvements to this package, prior to manufacturing. Demographic
information was also collected to aid in the marketing aspects of the manufactured
package.

This chapter is divided into two sections. Section one includes test subject age
range, gender, and physical condition categories, such as normal and secondary. Section
two includes test subject feedback on specific components of the newly designed
organizer/dispenser. Test subject solid oral medication/vitamin supplement and quantity
use, as well as pharmaceutical/OTC packaging ease of use and preference, were

included in the questionnaire.

59

Section 1: Test Subject Age Range and Sex, and Physical Condition Categories

Test Subject Normal and Secondary Physical Condition
One-hundred test subjects were interviewed. Fifty normal and 50 secondary

male and female test subjects aged 21 years and higher were interviewed. Of the normal
test subjects, 56% were male and 44% were female. Of the secondary test subjects, 26%

were male and 74% were female. (Figure 27)

 

1 Normal and Secondary Test Subject:
Physical Condition

w-

    

Test Subject, %
VI
0

Normal Secondary
Physical Condition Category

 

 

Figure 27 — Normal and Secondary Test Subject: Physical Condition

60

Test Subject Physical Condition per Age Range
Of the normal male test subjects, 82% were aged 21 — 45, 7% were aged 46 —

60, 4% were aged 60 — 77, and 7% were aged 77+. Of the normal female test subjects,

64% were aged 21 — 45, 18% were aged 46 — 60, 14% were aged 60 -— 77, and 5% were
aged 77+. Of the secondary male test subjects, 15% were aged 21 — 45, 38% were aged
46 — 60, 31% were aged 60 — 77, and 15% were aged 77+. Of the secondary female test
subjects, 11% were aged 21 — 45, 41% were aged 46 — 60, 30% were aged 60 -— 77, and

19% were aged 77+. (Figure 28)

 

Normal and Secondary Test Subject:
Physical Condition per Age Range

i I Normal Male

i I Normal Female

! El Secondary Male
11:1 Secondary Female

Test Subject, %

 

 

 

Age Range

 

 

Figure 28 — Normal and Secondary Test Subject: Physical Condition per Age Range

61

Secondary Test Subject Physical Condition
Of the secondary male test subjects, 69% had arthritis and 31% had other

physical disabilities. Of the secondary female test subjects, 81% had arthritis, 11% had

some type of stroke, and 8% had other physical disabilities. (Figure 29)

 

Secondary Test Subject:
Arthritis, Stroke, and Other Physical Condition

mag}

    

Test Subject, %
M
0

Arthritis Stroke Other

Physical Condition Category

 

 

 

Figure 29 — Secondary Test Subject: Arthritis, Stroke, and other Physical Condition

62

Section 2: Test Subject Feedback on Specific Components of the Newly Designed
Organizer/Dispenser

Four aspects of the package were asked about in the questionnaire. These
included the comfort of the handle, distance of the two buttons that are required to be
pushed simultaneously for normal and secondary people, improvements in medication
compliance because of the new package, and desire of owning the package if
manufactured. Test subject responses are as follows:

Package Method of Use was Easy to Understand
Of the normal males 54% strongly agree, 39% agree, 4% neither agree nor

disagree, and 4% disagree. Of the normal females 50% strongly agree, 41% agree, 5%
neither agree nor disagree, and 5% disagree. Of the secondary males 62% strongly
agree, 31% agree, and 8% neither agree nor disagree. Of the secondary females 38%
strongly agree, 46% agree, 11% neither agree nor disagree, 3% disagree, and 3%

strongly disagrees. (Figure 30)

 

 

 

 

 

 

Nomral and Secondary Test Subject: i
Package Method of Use was Easy to Understand
,\° ,, , , ,,,,,, ,
*3 } E2 Normal Male
0 1
IE I I Nomral Female
l 1
‘ g i E] Secondary Male
: [El ,Seeniaajsnrls
Strongly Agree Neither Disagree Strongly
Agree Agree Disagree
nor
Disagree
Test Subject Response J
Figure 30 — Normal and Secondary Test Subject: The Package Method of Use was
Easy to Understand

63

The Feel of the Handle is Comfortable
Of the normal males, 11% strongly agree, 46% agree, 11% neither agree nor

disagree, and 32% disagree. Of the normal females, 5% strongly agree, 64% agree, 5%
neither agree nor disagree, 18% disagree, and 9% strongly disagree. Of the secondary
males, 31% strongly agree, 46% agree, and 23% disagree. Of the secondary females,
22% strongly agree, 30% agree, 16% neither agree nor disagree, 19% disagree, and

14% strongly disagree. (Figure 31)

 

Normal and Secondary Test Subject:
The Feel of the Handle is Comfortable

     

 

 

 

 

 

100 , , .
m '5‘- b—Mw 3%?
80
.\° 70
‘5 60 I Nonml Male
0
§ 50 I Nonml Fermle
(g :3 El Secondary Male
[- 20 :1 Secondary Female
10 '
0
Strongly Agree Neither D'Bagree Strongly
Agree Agree nor Disagree
Disagree
Test Suljeet Response

 

 

Figure 31 — Normal and Secondary Test Subject: The Feel of the Handle is Comfortable

The Distance of the Two Buttons are at an Adequate Distance Apart
Of the normal males, 7% strongly agree, 64% agree, 11% neither agree nor

disagree, andl 8% disagree. Of the normal females, 9% strongly agree, 50% agree, 5%
neither agree nor disagree, 32% disagree, and 5% strongly disagrees. Of the secondary
males, 31% strongly agree, 31% agree, 15% neither agree nor disagree, 15% disagree,
and 8% strongly disagrees. Of the secondary females, 24% strongly agree, 19% agree,

8% neither agree nor disagree, 22% disagree, and 27% strongly disagrees. (Figure 32)

 

Normal and Secondary Test Subject:
The Distance of the Two Buttons are at an Adequate
Distance Apart

 
 
  
  
 
 

IFI Normal Male

.; I‘INomnl Fennle

,3? in Secondary Male
Iii: [El Secondary Female

Tes subject, %
LII
O

 

10 ,
0
Strongly Agree Neither Disagree Strongly
Agree Agree Disagree
nor
Disagree
Test Subject Response

 

 

 

Figure 32 — Normal and Secondary Test Subject: The Distance of the Two Buttons is
Adequate

65

The Distance of the Buttons is Comfortable for Individuals with Decreased Physical
Hand Dexterity, Such as Gripping or Pinching Strength

Of the normal males, 43% agree, 29% neither agree nor disagree, and 29%
disagree. Of the normal females, 9% strongly agree, 41% agree, 23% neither agree nor
disagree, 23% disagree, and 5% strongly disagrees. Of the secondary males, 23%
strongly agree, 23% agree, 23% neither agree nor disagree, 15% disagree, and 15%
strongly disagree. Of the secondary females, 14% strongly agree, 14% agree, 19%

neither agree nor disagree, 27% disagree, and 27% strongly disagree. (Figure 33)

 

Normal and Secondary Test Subject:
The Distance of the Buttons is Comfortable for
Individuals with Decreased Physical Hand Dexterity,
Such as Gripping or Pinching Strength

   
    
 
 

1
1
l

I I Nomral Male
I I Nome] Female

  

2 0 Secondary Male

Test Subject, %
“<3

30 as 1

20 ‘4 1% Female
10 h

0 .
Strongly
Agree Agree Disagree
nor
Disagree
Test Subject Response

 

 

 

Figure 33 — Normal and Secondary Test Subject: The Distance of the Two Buttons is
Comfortable for Individuals with Decreased Physical Hand Dexterity, Such
as Gripping or Pinching Strength

66

This Package will Aid in Medication Compliance for Both Individuals with or without
Physical Hand Dexterity

Of the normal males, 21% strongly agree, 57% agree, 18% neither agree nor
disagree, and 4% disagree. Of the normal females, 41% strongly agree, 45% agree, and
14% neither agree nor disagree. Of the secondary males, 38% strongly agree, 31%
agree, 15% neither agree nor disagree, 8% disagree, and 8% strongly disagrees. Of the
secondary females, 30% strongly agree, 35% agree, 16% neither agree nor disagree, 8%

disagree, and 11% strongly disagrees. (Figure 34)

 

Normal and Secondary Test Subject:
This Package W1“ Aid in Medication Compliance for
\ Both Individuals with or without
Physical Hand Dexterity

h—___
l I NomraI Male

‘\

l I Name] Female

Test Subject; %

! El Secondary Male
,_ 1CI Secondaryflmle

 

Strongly Agree Neither Disagree Strongly
Agree Agree Disagree
nor
Disagree

 

 

Test Subject Res ponse ‘

_ ”WW—J

Figure 34 — Normal and Secondary Test Subject: This Package Will Aid in Medication
Compliance for Both Individuals with or without Physical Hand Dexterity

 

67

If Manufactured, I have a Desire to Own and Use This Package
Of the normal males, 21% strongly agree, 39% agree, 25% neither agree nor

disagree, and 14% disagree. Of the normal females, 18% strongly agree, 45% agree,
23% neither agree nor disagree, and 14% disagree. Of the secondary males, 38%
strongly agree, 23% agree, 15% neither agree nor disagree, and 23% disagree. Of the
secondary females, 22% strongly agree, 27% agree, 16% neither agree nor disagree,

16% disagree, and 19% strongly disagree. (Figure 35)

 

Normal and Secondary Test Subject:
If Manufactured, I Have a Desire to
Own and Use this Package

 
  
  

  
  
 

‘ I Normal Male

l
‘ INorrml Female

Test Subject, %
Ur
0

El Secondary Male
g :0 Secondary Fermle

10 L
0 A ‘ ..
Strongly Agree Neither Disagree Strongly
Agree Agree Disagree
nor
Disagree
Test Subject Response

 

 

 

Figure 35 — Normal and Secondary Test Subject: If Manufactured, I have a desire to
Own and to use this Package

68

Chapter 6: Conclusion and Future Study

For this research, a package was designed to make medication compliance easier
for individuals with and without physical ailments. The child-resistant package allows
an individual to use only one hand to gain access to medications/vitamin supplements.

Although the data obtained from the questionnaire are unsupported opinions, it
does provide insight into the success the package, as well as information on how to
improve the package for the package research and development process.

Conclusion

These test results indicate that this package method of use is easy to understand
for a strong majority of the test subjects. However, the test results also indicate that the
handle design, as well as the distance between the two buttons, will need to be
ergonomically improved. A large percentage of test subjects believed the package
would aid in medication compliance for individuals with normal and with limited
physical hand dexterity. The proportion of test subjects that desire to own and use this
package, if it is manufactured, was not overwhelming. However, ergonomic
improvements to this package or future acceptance of the unfamiliar package
component use, such as the distance between the two buttons that must be pressed to
operate the package, might result in greater acceptance.

Whenever possible, designers who are attempting to meet the needs of the
elderly and disabled should follow the principles of universal design. However,
sometimes the pursuit of a universal solution may compromise function that is critical

to the user, in which case, it is not a universal solution. The challenge in these

69

circumstances is to achieve that function in as attractive and affordable manner as
possible. (Fisk, 1997)
Suggestions for Future Research

Child-Resistance
Because of the need for child-resistant packaging that is also senior friendly, the

hand span of children and adults should be studied and implemented into package
design.

Currently, this package cannot claim to be child-resistant; it has not been tested
for child-resistance. Prior to manufacturing, child-resistance of this package should be
tested using 16 CFR 1700.20, testing procedure for special packaging.

Solid Oral Requirements
Only solid forms of medication/vitamin supplements that do not reach their

critical point of shelf-life within one week of constant exposure to environmental
humidity can be used in this dispenser package to ensure maximum supplemental
benefits.

Currently, the package is classified as well closed, meaning that the package
protects its contents from extraneous solids and from loss of the contents under the
ordinary or customary conditions of handling, shipment, storage and distribution.
Perhaps future developments would enable the package to be tightly closed, which is
preferred over well closed. According to the United States Pharmacopeia, Chapeter
<671> Containers - Permeation, A tightly closed package protects the contents from
contamination by liquids, solids, or vapors, from the loss of the article and from
efilorescence, deliquescence, or evaporation under ordinary or customary conditions of

handling, shipment, storage, and distribution and is capable of a tight package reclosure.

70

Increased Independence for Mentally Handicapped Individuals
This package may be useful for individuals who are mentally handicapped. The

transparency of the package would enable the mentally handicapped individual to see
the medication inside the package. If the mentally handicapped individual knows that
the medication inside the package needs to be taken, and also knows how to access the
medication, this package could increase independence for the mentally handicapped
individual. A Pharmacy or care taker can refill package for the individual.

Compliance Packaging
Currently, the package cannot be considered a compliance package because the

individual compartments are not labeled according to day of the week; Sunday,
Monday, Tuesday, Wednesday, Thursday, Friday and Saturday. These labels should be

used on this package for this package to be considered a compliance package.

71

Appendix 1: Human Percentile Conversions

72

Any percentile value of measurements may be calculated using the population

percentile conversion table. (Table 5)

Table 5 - Population Percentile Conversion (Tilley, 1993)
% Included

 

  

  

Percentile

    

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

99.9 = Mean + (3 * SD) 99.8
99.5 = Mean + (2.576 * SD) 99
99 = Mean + (2.326 * SD) 98
97.5 = Mean + (1.95 * SD) 95
97 = Mean + Q88 * SD) 94
95 = Mean + (1.65 * SD) 90
90 = Mean + (1.28 * SD) 80
85 = Mean + (1.04 * SD) 70
80 = Mean + (0.84 * SD) 60
75 = Mean + (0.67 * SE 50
50 = Mean

25 = Mean — (0.67 "‘ SD) 50
20 = Mean — (0.84 * SD) 60
15=Mean—(1.04* SD) 70
10=Mean—(1.28 * SDL 80
5 = Mean— (1.65 * SD) 90
3 = Mean — (1.88 * SD) 94
2.5 = Mean — (1.95 * SD) 95
1 = Mean — (2.326 * SD) 98
0.5 = Mean — (2.576 * SD) 99
0.1 = Mean - (3 * SD) 99.8

 

 

 

 

SD = standard deviation, which can be found by the formula:

 

2
SD = 2(d)
N
Where 2 = summation
d = difference between one person’s measurements and the arithmetic
mean of that measurement
N = number of people in the survey

There is a particular standard deviation for every measurement and every sample. We
have chosen to accommodate 98% of the US. population, which lies between the 99th
percentile and the 1St percentile, for product designs for civilians. Any lower percent
excludes a good number of tall operators. If one prefers a different percentile, the
standard deviation can be calculated from data on anthropometric diagrams.

73

For example:

2.32 SD = 99 percentile stature — mean stature

D = —6'—5— = 2.8" (71 mm)
2.326

01'

2.326 SD = mean stature — 1 percentile stature

SD = 3'3— : 2.8"(71 mm)
2.326

74

Appendix 2: ZPrinter 310 System

75

The prototype parts were printed using the ZPrinter 310 system. (Figure 36)

Some of the system specifications and descriptions are provided. (Table 6)

 

Figure 36 — ZPrinter 310 System

Table 6 — ZPrinter 310 System General Specifications (Zcorporation, 2003)

 

 

 

 

 

 

 

Specification Description

Build Volume 8” * 10” * 8” (203 * 254 * 203 mm)

Layer Thickness User selectable at time of printing; .003” - .010” (.076 - .254
mm)

Equipment 29” * 32” * 43” (74 * 81 * 109 cm)

Dimensions

Equipment Weight 250 lbs. (113 kg)

System Sofiware Z Corporation’s proprietary software accepts solid models in

 

STL, VRML and PLY file formats as input. ZPrint software
features 3D viewing, text labeling, and scaling fimctionality.
The software runs on Microsofi Windows“ NT, 2000
Professional and XP Professional.

 

76

 

Appendix 3: Sketches

77

 

--. -. O~‘~--~,45~ .

08 April, 2003

Figure 37 - Solid Oral Organizer Sketch

78

 

Lock

   

 

Open/Close indicator (color)

 

 

 

 

 

 

 

 

 

 

 

 

,, .. - .,,_., a. ._ ,1
o o~~.<qg_._,-fl_‘_(-
“.0 .

 

mVIN-MHMW‘HMIHVAMI-“J --,........ . . .. 08Apfi1‘2003

Figure 38 — Solid Oral Organizer Sketch 2

79

 

 

 

 

 

 

09 April. 2003

 

 

 

 

 

Figure 39 - Solid Oral Organizer Sketch 3

80

 

09 April, 2003

 

Figure 40 -— Solid Oral Organizer Sketch 4

81

When locked. door won't open
When unlocked. door and top will open.

 

 

 

  
 

‘ Push button - pill out.
Let go.
Self advancing.

Push button - advance - pill out.
Let go - lock.

in April. 2003
Figure 41 — Solid Oral Organizer/Dispenser Sketch

82

”K Lock
" ‘ . (Iv , I. Is! click unlocks. advances. and dispenses.
‘ ’1'an clock locks.

    
  

L -1 ks, , ‘
Advance etgo 0c andfi‘lt-nnccs

 

7 L‘ A Closure my: on.
i C ., ' Unlocks when in “open“ position.
,3 CR 3 .7 'i Locks when in closed position
: Cominuous closure lock.
' Push and turn. I I April, 2003

Figure 42 — Solid Oral Organizer/Dispenser Sketch 2

 

 

12 April. 2003

Figure 43 — Solid Oral Organizer/Dispenser Gear and Ratchet Sketch

83

 

 

 

 

 

 

I2 April, 2003

 

Figure 44 — Solid Oral Organizer/Dispenser Gear and Ratchet Sketch 2

84

    

‘ ' . . .. t .
‘K I ' I ’ "‘ |
n. 'l I
. an .
' ~. “‘17 l - I . ”.77, ,v. .
. "r
". ‘
-. _ ,
. ‘l

:2 April, 2003

Figure 45 — Solid Oral Organizer/Dispenser Gear and Ratchet Sketch 3

85

Appendix 4: Package Drawings

86

 

Figure 46 — Top View of Package

     
   
   

0
0‘5“ 0%

‘1 CLOSE ‘4
LTIGHTLY’I‘

Figure 47 — Top View of Package with Closure and Cover Removed

87

 

Figure 48 — Top Cross-Section View of Package Second Closing and
Advancement Mechanism

 

Figure 49 — Top View of Package Second Housing

88

 

 

 

80
8] 88
:- 89
46
82
53 70 52

93—->

846 51 50 40

42
41

45

Figure 50 — Top View of Package without Closure and Cover

 

 

 

80.
2.1 88
:- 89
46
53 82 70 52
9337—»

53 234-6 51 50 40
42

41

45

Figure 51 — Top Cross-Sectional View of Package through Circular Wall of
First Housing

89

+_40

 

Figure 52 -— Top View of Package First Housing

90

112 Y¥99

  
   
 
    
   

113

119 114

l

117
115-—9>

  

l

 

118 1 0

Figure 53 - Top View of Package Lock Release, Trigger, Ratchet, and Break in
Relation to One Another

128

 

Figure 54 — Top View of Package First Gear and Second Gear in Relation to
One Another

94
97-———-'

Figure 55 — Top View of Package Sliding Door

91

72
71

7 {—70

Figure 56 — Top View of Package Wheel Cap

7 Q {—70
74
73

Figure 57 — Bottom View of Package Wheel Cap

72
71

7. 4—70
74

Figure 58 — Top View of Package Wheel Cap 2

      
 
 
     

D
85“ 0‘2 ,4
Q CLOSE 7’ 63
TIGHTLY’I‘ *—
1/10 r088; .5

Figure 59 — Top View of Child-Resistant Closure

92

60

.1

Figure 60 — Top View of Package Clear Cover

 

 

Figure 61 — Bottom View of Package Clear Cover

93

 

 

 

 

4—80

 

 

 

 

 

 

 

 

Figure 62 - Top Perspective Exploded View of Package

94

 

 

 

53 50
57 41

 

 

 

97

93.}. llS—‘> 18
19
l .

 

Figure 63 — Bottom Perspective Exploded View of Package

95

 

Figure 64 — Top Perspective View of Package

 

Figure 65 — Top Perspective View of Package with Separated Clear Cover, First
Housing, and Second Housing

96

 

 

 

 

Figure 66 — Bottom Perspective View of Package

 

 

 

 

 

 

 

 

 

 

 

 

J——J

 

Figure 67 — Back View of Package

 

Figure 68 — Front View of Package

 

Figure 69 — Front View of Package with Exposed Sliding Door Chamber

97

 

 

 

I’fl‘l

Figure 70 — Side Cross-Sectional View of Package Wheel Cap

 

Oi"

Figure 71 — Bottom Perspective View of Wheel Cap

(t.

Figure 72 - Top Perspective View of Wheel Cap

 

 

 

 

e e

Figure 73 — Side Cross-Sectional View of Package Child-Resistant Closure

 

98

1. Push and hold button to unlock wheel

 

Figure 74 — Top View of Package Inner Workings which Illustrate how to Advance
Rotary Wheel with Lock Release in Unlocked Position

Continue holding button

   
 

2. Push button to )
advance wheel

Figure 75 — Top View of Package Inner Workings which Illustrate how to Advance
Rotary Wheel by Pulling Trigger

99

 

Q0 3. Push slide door
0 to open position
to dispense

Figure 76 — Top View of Package Inner Workings which Illustrate how to Access the
Contents with Rotary Wheel in a Resting Position

100

 

1. Push down and turn closure

Figure 77 — Top View of Package which Illustrates How to Refill Package by
Disengaging Child-Resistant Closure

2. Remove closure and lid to refill

 

Figure 78 — Top View of Package which Illustrates How to Refill Package by
Removing Closure and Cover

101

Table 7 — Package Part Legend

10.
ll.
12.

13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.

31.
32.
34.
35.
36.
37.
38.
39.
40.
41.
42.
45.
46.
50.
S 1.
52.
53.
54.
55.
56.
57.
58.

Second housing

Second housing — edge wall

Second housing - bottom surface

Second housing — enclosed surface

Second housing — side rim

Second housing — first housing bottom rim rest
Second housing — first opening

Second housing — second opening

Second housing - third post

Second housing — third post top

Second housing — third post face

Second housing — first screw housing

Second housing — first screw housing open threaded circular cavity
Second housing — second post

Second housing — first axle

Second housing — second screw housing

Second housing — second screw housing open threaded circular cavity
Second housing — fourth post trigger runner top
Second housing — fourth post trigger runner

Second housing — fourth post

Second housing — lock release base

Second housing — lock release base open spring cavity
Second housing — lock release rest

Second housing — first post

Second housing — second axle

Second housing - second axle screw housing open circular cavity top
Second housing - second axle screw housing open circular cavity bottom
Second housing — ratchet spring base

Second housing — ratchet spring open cavity

First housing

First housing — bottom wall

First housing — top face

First housing — trigger opening

First housing — lock release cavity

First housing - circular wall

First housing — circular wall inner surface

First housing — circular wall outer surface

First housing — circular wall opening

First housing — enclosed portion of top face

First housing — second housing fitment side

First housing — circular base open cavity

First housing — slide door housing outer side

First housing — support plate tab fitment notch

102

60.
61 .
62.
63.
64.
65.
66.
67.
68.
69.
70.
71.
72.
73.
74.
75.
76.
80.
81.
82.
83.
84.
85.
86.
87.
88.
89.
90.
91.
92.
93.
94.
95.
96.
97.
99.
1 00
1 01
l 02
103
1 O4
105
106
107
108
109

Segment (compartment) cover

Segment cover — edge

Segment cover — continuous thread closure engagement
Continuous thread child-resistant closure

Continuous thread child-resistant closure — top surface
Continuous thread child-resistant closure — side (gripping surface)
Continuous thread child-resistant closure — rim

Continuous thread child-resistant closure — circular cavity
Continuous thread child-resistant closure - segment cover bead engagement
Continuous thread child-resistant closure — wheel cap engagement threads
Wheel cap

Wheel cap — top face

Wheel cap — continuous closure engagement threads
Wheel cap — bottom face

Wheel cap — circular cavity

Wheel cap post bed

Wheel cap — side

Rotary cam-wheel

Rotary cam-wheel — rim

Rotary cam-wheel — wheel cap rest

Rotary cam-wheel — circular base

Rotary cam-wheel — open circular cavity top

Rotary cam-wheel — open circular cavity bottom

Rotary cam-wheel -— pegs

Rotary cam-wheel — segments

Rotary cam-wheel - spokes

Rotary cam-wheel — wedge shaped pockets (compartments)
Support plate

Support plate — attachment bed

Support plate — fitment tab

Sliding door

Sliding door — closed end

Sliding door — bottom edge

Sliding door — open end

Sliding door — tab

Break

Break — circular cavity bottom

. Break — circular cavity top

Break — flexible tooth

. Lock release

. Lock release — second end

. Lock release — first end

. Lock release — open spring cavity
. Lock release — bottom end

. Ratchet arm — third end

. Lock release — hole

103

1 l 0. Ratchet arm

111.

112.
113.
1 14.
115.
116.
117.
118.
119.
120.
121.
122.
123.
124.
125.
126.
127.
128.
129.
130.
131.
132.
133.
134.

Ratchet arm — first end

Ratchet arm — second end

Ratchet arm — base

Ratchet arm — circular open cavity
Trigger

Trigger -— first side

Trigger — second side

Trigger — outer side

Trigger — open cavity

First gear

First gear —- circular cam-wheel

First gear - regularly spaced projections of circular cam-wheel
First gear — teeth

First gear — raised circular cavity ridge
First gear — trigger runners

Second gear

Second gear — circular depression
Second gear — teeth

Second gear — open circular cavity
Second gear — circular depression notches
Springs

Springs - lock release

Springs — trigger

Springs - ratchet

104

Appendix 5: Consent and Confidential Agreement Forms

105

INSTRUCTIONS AND RESEARCH CONSENT FORM
Deter-miningtlreEaeeoIUuota Newly DevelopedChfld-RalataatUI‘ClPhamaeaaflcaISofld
Oral Madman/Vitamin Supplemental Organizer-(Dinner- Package

YouaruatbeZI ymofageaoflermdabbbmapachgewlflrmmhmwpundpdehthhmdy.

Yonmbehgaskedtopartietpatehastudythudetemures ifdremlydevelopedpadtagelawytohandlouwellu
easytoueeforpeoplewithandwhtheaeuedlmdMyJ‘hemofdrtuhrdyhto:
I. detennineifthetwobuttuudrdmtequiedmbepressedmusethispachgemda
comfortable distance marine“ as package feel.
2. determhteifthemeofdrenewpackageiscasytoleammdtow

Beforetostingbeginrywwillbeaskedtosignaeoofidentialdisclosnreagreetnetrtinwhicheachreoetvhsputyapeee
neitherto use the Confidential Information for my purpose other th- evaluatloo nortoprovlde the Confidential
Infonnationtomythirdpartyodrerthanasignatorytothiswrtfotaperiodofflve(5)yearaupontheraeeiptofthe
confldeutlallnl‘ormation. Youwtll alsobeaskedmslgnafomgrmhgpennhsionforphotoyaphatobehkenofyou
duringyoruparticipationinthisreeearch.

InexchangeforyoorparticipationIntlrlssardyyouwillrecelveachotceofone(l)oftho followingaoack items:
I. NaureValleyGnnchyOtmolaBm—Oats'NHoneyNetV/tlmau)
2. Combos Snacks - CheddarCheeee CrackerNet Wt I.7Ooz(48.23)

Dnringthecotmeot‘thestudyyoumllbeaskedtowatdra30minationofdrenewpachgebeirgueed,togain
undentandhrgofhowtheNapawan;whuhappeoswhurthotwohntonsmpmhedmdlspenaeofwlidoral
medication/vitamin supplemental package. You will alsobe asltedtoh-rdlea non—workingpmtotypoofthenew package
forthedeterminaton ofyourcomfortwhenhandlingurdusingdienewpackagemenyouwillbeaskedwanmaa
many questions on questionnaire, as acculely as possible. At anytime din-tag this testyou may requeetto Viewthe 3D
animationandhmdlethe newpaekageooo-wakingpotaypeagmtohebyoumdrequmlhaem I7
questiomtoanswerondroqmtiomah.

Ifywhmmyquesdmsnmytinepluseukfleenfiemionwlflhumxmywminutes.
Therearemhrtrnalpom’blertsbofputieipdlnginthhresench.

Ifyou have anyqueetioosorcornmuregudtngthis study, please contactDr. Hmld Hughes. Professorot'l’ackaging at
Michigan State University at 517-353-6462 or harold@msu.edu

YouanfreemdhcaninueyompmlctpadontnthisnudyuanytinaWpandty.
It'youchoosetodlsconthueyowpartlcipationyouwtllstiflreceiveone(l)oftheanacltlnmlletedabove.

Thereeultsofthisstudywillbeneatedioatrictconfidencelnthatyornnunewillnotbeassociatedwithmyofyour
respowes. Youprtvacywlllbepmtecmdtothemaxlmunextentofthelaw.

Youareawrethatyotn'pttieipuionhthissmdydoernotgumnteeanybareflctalmltsmmeaceptdratyom
puficipationinthisraaecchwillprovideeocletywithapackagethatpeoplewithdiaabtlfiiucanm

lt'youhave any questions orcoocerruregardingyourrtghtnaaatndy participmt, crate dissatisfiedatanytime with any
aspect of your study, you may contact - anonymously it‘ you wish - Peter Vasilenko. PhD., Chair ofthe University
Committee Involving Human Subjects (UCRIHS) by phone: (517) 355-2180. fax: (517)432-4503. e—rnall:
MM or result mail: 202 Old: Hall. East Lansing. MI 48824.

lvoluntarilyagreetoputicipateinthestudydetmniningthecomfortmduseofdtenew.packnge.

 

 

Signature: UCRIHS APPROVAL FOR
THIS project EXPIRES:
Date:
You will be provided with a copy ofyour signed consent rorm. OCT 1 3 2004
senewu APPLCATDN
Sir uoum PRIOR To
move omen) com-mus

106

MEDIA CONSENT FORM
Determining the Ease of Use of a Newly Developed Child-Resistant OTC/Pharmaceutical Solid
Oral Medication/Vitamin Supplemental Organizer/Dispenser Package

Photos andlor video will be taken, with your permission. during your participation in this testing. This media will be used
for a slide show that will be shown, with male. prior to thesis defense presentation, or during thesis defense. only. Your
privacy will be protected to the maximum extent of the law.

You may decide not to have your picture taken at any time during your participation without penalty.

If you have any questions or comments regarding this study. please contact Dr. Harold Hughes, Professor of Packaging at
Michigan State University at 517-353-6462 or harold@msu.edu.

It‘ you have any questions or concerns regarding your rights as a study participant, or are dissatisfied at any time with any
aspect of your study, you may contact - anonymously if you wish - Peter Vasilenko, PhD., Chair of the University
Committee Involving Human Subjects (UCRll‘lS) by phone: (5 I 7) 355-2180. fax: (517) 432-4503, o-mail:
uchrisd‘tlmsuedu. or regular mail: 202 Old: Hall. East Lansing. MI 48824.

1 voluntarily agree to p-ticipate have media. such as those gathered by camera mid video. use of the new package.

Signature:

 

Date:

 

You will be provided with a copy of your signed media consent form.

107

ral-

MICHIGAN STATE UNIVERSITY
OFFICE of INTELLECTUAL PROPERTY

CONFIDENTIALDISCLOSURE AGREEMENT

The undersigned patties (herein “Party” or “Parties” as appropriate under the context)
agree to the following conditions for the mutual disclosure and exchange of valuable
confidential or proprietary materials and information (herein “Confidential Information”)
relating to DESIGNING A SENIOR FRIENDI..Y OTC/PHARMACEUTICAL SOLID
ORAL MEDICATION/VITAMIN SUPPLEMENTAL ORGAN IZER/DISPENSER
PACKAGE:

The Confidential Information may include but is not limited to products, processes,
techniques, know-how, trade secrets, scientific knowledge, materials, sequences,
inventions, machines, data, formulas, samples. models. systems, networks, business
plans. customer requirements. software, designs. drawings. schematics. sketches.
photographs, digital outputs, specifications, documentation. reports, and/or studies of the
originating Party.

In consideration for such disclosure, each receiving Party. agrees neither to use the
Confidential Information for any purpose other than evaluation nor to provide the
Confidential Information to any third party other than a signatory to this Agreement for a
period of five (5) years from the date of receipt of the Confidential Information. Nothing
herein shall grant or imply a license or right to use any Confidential Information. or any
patents, copyrights. trademarks. and trade secrets of the disclosing Party, except to the
extent necessary for the evaluation contemplated herein.

All Confidential lnfomration provided in a tangible form will be marked as
“Confidential.” A Party disclosing Confidential Information in verbal or other non-
tangible form shall provide the other Parties written notice within thirty (30) days after
each such communication identifying the confidential aspects of the disclosure.

Each receiving Party agrees to limit access to the other Parties’ Confidential Information
only to its employees. students. research assistants, postdoctoral fellows. agents, vendors
and consultants for whom such access is necessary, and only to the extent that such
individuals have an obligation of confidentiality to said receiving Party. The Parties shall
exercise reasonable care to prevent disclosure of the Confidential Information to any third
party that is not bound by this Agreement.

Each receiving Party agrees to make its evaluation as promptly as possible and, upon
request by the providing Party at any time, agrees to return any or all samples and

lof2

108

Confidential Information together with any and all cepies thereof, with the exception of
one copy of Confidential Information which may be held for archival purposes only.

6. The secrecy and non-disclosure obligations of this Agreement do not apply to
information that:

a) at the time of the disclosure was generally available to the public or thereafter has
become generally available to the public through no breach of the Agreement by the
receiving Party.

b) the receiving Party can show by written records was in its possession prior to the time
of disclosure and was not acquired. directly or indirectly, from the disclosing Party.

c) the receiving Party can show by written records was discovered or developed
independently. without use or knowledge of the Confidential Information.

d) the receiving Party can show by written records was obtained from a third party that
reasonably believed it was under no obligation of confidentiality or secrecy to the
originating Party.

e) is required to be disclosed by law. legal process. government agency, or court order.

7. Modifications, extensions, or amendments to this Agreement shall be done in writing and
executed by all Parties to this Agreement. The Parties agree that any photopr or
electronically produced copy of this fully executed original Agreement shall have the
same legal force and effect as a copy of the Agreement that has the original signatures.

8. This Agreement shall be executed by all Parties through duly authorized representative
and shall be effective as of the date of last signing.

 

 

 

MICHIGAN STATE UN ;R7TY Party:
By: 7%,“? (ELLLCEE; 3! U 4176,1454 {1‘74 By:
M /

Typed ame: Loraincf Hudson Typed Name:

 

Title: Director, Office of Intellectgg! Property Title:

 

 

 

 

 

 

 

Address: 246 Administration Building Address
East Lansing, MI 48824-1046
/ . .
Date: I/J i / C" :2) Date:
20l‘2

109

Appendix 6: Questionnaire

110

Questionnaire

Determining the Rose of Use of a Newly Developed Child-Resistant OTClPlarrnneoutienl

Solid Oral Mediation/Vitamin Supplemental Organizer/Dispenser Package

A. General Information (Please check all that apply)

I. What is your age?
I". 21 — 45 I.” 60 - 77
U 46 - 60 I." 77+
2. What is your sex?
Tl Male
"I Female

B. Health and Solid Ornl Daily Consnmptlon

 

 

 

3. Physical condition: (Please check all that apply)
fl Normal
‘I Secondary .... [‘7 Arthritis -+ F Osteo Arthritis
I" Rheumatoid Arthritis
L‘ Other
I; Stroke —o f“ Minor
I“. Major—t paralysis it Yes
.'I No
LI Other:
4. Solid oral VitaminfSupplcment
Do you take medication/vitamin supplements on a daily basis and how many?
r '1 Yes .... Solid Oral fl Yes --» I'l Medication #_______
I'l Vitamin Supplement #______
l I Both it”
Liquid I 1 Yes
I I No '
C. Packaging
5. In most cases, what types of containers do your OTClpharrnaceutical/vitamin
supplemental solid orals come in? (Please check all that apply)
Fl Paperboard carton with blister sheets
El Bottle with child resistant closure
:7 Bottle without child resistant closure
TTI Other.
6.

Of the above child resistant containers that you use please rate the containers for ease of
use (Please check one)

’1 Very easy
it About right
.‘1 Somewhat difficult

{.1 Very difficult (80 '0 "‘3’“ 008°)

111

‘7. Do you use pill organizers/dispensers?

IIYes
E’INo

8. What kind of pill organizer/dispenser do you, or would you prefer to use?

Tl Daily - child resistant
{.1 Daily -— not child resistant

i7. Multi dose per day - child resistant
[7 Multi dose per day - not child resistant

I” None

0. Newly Designed Package Questions

Please indicate how much you agree or disagree with the following statements

concerning the newly designed package?

 

   
        
      
   

Statements

9. re package method of use was easy
to learn

Strongly
agree

Neither
Agree or
Disagree

Disagree

 

Strongly
Disagree

 

Ill. The feel of the handle is comfortable

 

an adequate distance apart

ll. The distance of the two buttons are at

 

12. fire distance ol‘ the buttons is
comfortable for individuals with
decreased physical hand dexterity, such
as gripping or pinch strength

 

the dispenser I use is child-resistant

13. I would feel comibrt in knowing that

 

14. This pacEage will aid in medical
compliance for both individuals with or
without physical hand dexterity

 

15. If manufactured, l have a desire to
own and use this package

 

 

 

 

 

 

 

 

You have completed this questionnaire.
Please return it to Amy S. Houghtaling.

Remember to get your compensatory award.

Q Thank You 9

112

Appendix 7: Questionnaire Data

113

Section 1: Secondary Test Subject Information

Secondary Test Subject Physical Condition
Of the secondary test subjects 69% male and 81% female test subjects had

arthritis, 11% female test subjects had strokes, and 31% male and 8% of female had

other kinds of physical aliments, (Figure 79)

 

Secondary Test Subject:
Arthritis, Stroke, and Other Physical Condition

    

88

70

3

I Male
I Fermle

50

8

30

Test Subject, %

8

10 *

O

Arthritis Stroke Other

Physical Condition Category

 

 

 

Figure 79 — Secondary Test Subject: Arthritis, Stroke, and Other Physical Condition

114

Secondary Male Test Subject Physical Condition
Of the secondary male test subjects, 33% of age range 46 — 60, 33% of age

range 60 — 77, and 33% of age range 77+, had unspecified arthritis. Of the secondary
male test subjects, 14% of age range 21 -— 45, 43% of age range 46 — 60, 29% of age
range 60 — 77, and 14% of age range 77+ had rheumatoid arthritis. None of the

secondary male test subjects tested had osteoarthritis. (Figure 80)

 

Secondary Test Subject:
Male Arthritis Condition per Age Range

      
  

 

1w "1: fi_—.
90 ‘ ‘IUnspecified

°‘° 33

g. 60 tIOsteo

'2 5° 2

2 40 lL'IRheurmtoid

8 30 ‘

[- 20 ‘
10 I._. , i D Both Osteo and
0 ' mlm’j Rheumatoid

21 - 45 77+

 

 

 

Figure 80 — Secondary Test Subject: Male Arthritis Condition per Age Range

115

None of the secondary male test subjects had any type of stroke condition.

(Figure 81)

 

Secondary Test Subject:
Male Stroke Condition per Age Range
90 l

    

 

7‘ I Minor
' ; IMajor
U Both

Test Subject, %
8

 

 

 

21 -45 46-60 60-77 77+
Age Range

 

 

 

Figure 81 — Secondary Test Subject: Male Stroke Condition per Age Range

116

Of the secondary male test subjects with other physical conditions, 50% of age
range 21 — 45, and 50 % of age range 46 — 60, had a disabled hand or arm. Other
secondary male test subject physical conditions, such as conditions like Ankylosing
Spondylitis, accounted for 67% of age range 46 — 60 and 33% of age range 60 — 77.

(Figure 82)

 

Secondary Test Subject:
Male Other Condition per Age Range

  
 
  
   

. Fibromyalsia
I Multiple Sculosis

Test Subject, %
8

3o _. CI Disabled Hand/Arm
20 . D Other
10
0
21 - 45 46 - 60 60 - 77 77+
Age Range

 

 

 

Figure 82 — Secondary Test Subject: Male Other Condition per Age Range

Of the secondary male test subjects having multiple physical conditions, 100%

of age range 60 — 77 had a combination of rheumatoid arthritis and other. (Figure 83)

 

Secondary Test Subject: I Rheumatoid Arthritis and Mini
Male Multiple Physical Conditions per Age Range

Stroke

I Rheurmtoid Arthritis and Major
Stroke

Cl Rheurmtoid Arthritis and Other

E] Osteo Arthritis and Minor Stroke

Test Subject, %

I Osteo Arthritis and Major Stroke

 

I Osteo Arthritis and Other
21-45 46-60 60-77 77+

Age Range I Osteo and Rheurmtoid Arthritis
and Other

 

 

 

 

 

Figure 83 — Secondary Test Subject: Male Multiple Physical Conditions per Age Range

117

Secondary Female Test Subject Physical Condition
Of the secondary female test subjects, 25% of age range 21 — 45, 25% of age

range 46 — 60, 25% of age range 60 — 77, and 25% of age range 77+, had unspecified
arthritis. Of the secondary females, 8% of age range 21 — 45, 31% of age range 46 — 60,
38% of age range 60 — 77, and 23% of age range 77+ had osteoarthritis. Of the
secondary female test subjects, 17% of age range 21 — 45, 42% of age range 46 — 60,
33% of age range 60 — 77, and 8% of age range 77+ had rheumatoid arthritis. Of the
secondary female test subjects, 50% of age range 46 — 60 and 50% of age range 60 — 77

had both osteoarthritis and rheumatoid arthritis. (Figure 84)

 

Secondary Test Subjects:
Female Arthritis Physical Condition per Age Range

  
 
 
 
 

" TETUnspecified

.' i

_ l

2 ‘IIOsteo

40 Z I(lItheurmtoid

Test Subject, %
(J!
o

 

so >: ~- __ ; 2:
20 ' E1 Both Osteo and
13 7 a MRheunitpid
2] - 45 46 - 60 60 - 77 77+
Age Range

 

 

 

Figure 84 — Secondary Test Subject: Female Arthritis Physical Condition per
Age Range

118

Of the secondary female test subjects, 33% of age range 46 — 60, 33% of age
range 60 — 77, and 33% of age range 77+ had minor stroke conditions. Of the secondary
female test subjects, 100% of age range 46 - 60 had major stroke conditions. (Figure

85)

 

Secondary Test Subject:
Female Stroke Physical Condition per Age Range

r—I

TestSubject,%
o8888885‘888

    

 

 

 

 

21 -45 46-60 60-77 77+
Age Range

 

 

 

Figure 85 — Secondary Test Subject: Female Stroke Physical Condition per Age Range

119

Of the secondary female test subjects with other physical conditions, 100% of
age range 46 — 60 had fibromyalsia, 100% of age range 46 — 60 had multiple sclerosis,
30% of age range 46 — 60, 30% of age range 60 — 77, and 40% of age range 77+ had

physical ailments, such as congenital skeletal deformities. (Figure 86)

 

  
 

 

Secondary Test Subject:
Female Other Physical Condition per Age Range
100
90
g 80
J 70 _.‘_.—
.3 60 Frbromyalsra
a 1513 I Multiple Sculosis
g 30 DBOth
[- 20 D Other
10 ’
0 . .. .. . . . . . .. ,
21 - 45 46- 60 60- 77 77+
Age Range

 

 

 

Figure 86 — Secondary Test Subject: Female Other Physical Condition per Age Range

120

Of the secondary female test subjects that had multiple physical conditions,
100% of age range 46 — 60 had both rheumatoid arthritis and major strokes, 50% of age
range 46 — 60 and 50% of age range 60 — 77 had both rheumatoid arthritis and other,
29% of age range 46 —— 60 and 29% of age range 60 — 77 had osteoarthritis and other,

and 100% of age range 46 — 60 had minor strokes and other. (Figure 87)

 

1

 

I Rheumatoid Arthritis and

Secondary Test Subject: Mini Stroke
Female Multitple Conditiom per Age Range I Rheumatoid Arthritis and

Major Stroke
100 ’ j 121 Rheurmtoid Arthritis and

l
i U Osteo Arthritis and Minor
roke
I Osteo Arthritis and Major

Stroke
1 I Osteo Arthritis and Other

    

Test Subject, %
8

 

. 1
30 m \ I Osteo and Rheumatoid
20 g ‘ 1 Arthritis and Other
10 a ' ‘ Ell Minor Stroke and Other
0 l I Major Stroke and Other
21-45 46-60 60-77 77+
Age Range I Osteo and Rheumatoid
Arthritis, Stroke, and Other

 

 

 

 

Figure 87 — Secondary Test Subject: Female Multiple Conditions per Age Range

121

Section 2: Test Subject Solid Oral Medication/Vitamin Supplement and Quantity Use

Normal and Secondary Solid Oral Medication/Vitamin Supplement and Quantity Use
Of the normal male test subjects within age range 21 — 45, 4% consumed

medication only, 39% consumed vitamin supplements only, and 57% neither
medication nor vitamin supplements only. Of the normal female test subject age range
21 — 45, 36% consumed vitamin supplements only, 14% consumed both medication and
vitamin supplements, and 50% consumed neither medication nor vitamin supplements.
Of the secondary male test subject age range 21 — 45, 50% consumed both medication
and vitamin supplements, and 50% consumed neither medication nor vitamin
supplements. Of the secondary female test subjects within age range 21 — 45, 25%
consumed medication only, and 75% consumed neither medication nor vitamin

supplements. (Figure 88)

 

Normal and Secondary Test Subject:
Solid Oral Medication and Vitamin Supplement
Combination Consumption - Age Range 21 - 45

   
 
 

(EEEEF_'
I Nonml Fermle

40 .. , fi 1‘ Cl Secondary Male
3° ¢ m‘

Test Subject, %
8

 

EVSecondary Femfi

 

10'
0.
r: 3 ==£ o
2 r: o"'= ‘i
=0 -Eo o
13>: " >, was 2
0" EE— “3:5
65 225 2>2
u "D- “'9“
2 >e §=s
m “w

Medication and Vitamin Supflement
Comlination

 

 

 

 

 

Figure 88 — Normal and Secondary Test Subject: Solid Oral Medication and Vitamin
Supplement Combination Consumption — Age Range 21 — 45

122

Of the normal male test subjects within age range 46 - 60, 50% consumed both
medication and vitamin supplements, and 50% consumed neither medication nor
vitamin supplements. Of the normal females within age 46 — 60, 25% consumed only
medication, 25% consumed both medication and vitamin supplements, and 25%
consumed neither medication nor vitamin supplements. Of the secondary male test
subjects within age range 46 — 60, 60% consumed medication only, and 40% consumed
both medication and vitamin supplements. Of the secondary female test subjects within
age range 46 — 60, 33% consumed only medication, 7% consumed vitamin supplements
only, 47% consumed both medication and vitamin supplements, and 13% consumed

neither medication nor vitamin supplements. (Figure 89)

 

 
       
      

Normal and Secondary Test Subject:
Solid Oral Medication and Vitamin Supplement
Combination Consumption - Age Range 46 - 60
100 .-
90 f-_
,\° 80 ma“
.5 70 5 INorrml Male
9" 60 V INomanermle
3 5° W m
.5 30 fie EISecondary Male
; f3 . DSecondary People
0 2:1"

= '0 r: W o

2 E' c ' E r:

‘5 .2: E E >. g g ‘5’ 2°

2 - o .2 o

'0 5 g 3 5 ~ > —

g > a B 1: E

5; E 5 :2
Medication and Vitamin Supflement
Comlination

 

 

 

Figure 89 — Normal and Secondary Test Subject: Solid Oral Medication and Vitamin
Supplement Combination Consumption - Age Range 46 — 60

123

Of the normal male test subjects within age range 60 — 77, 100% consumed both
medication and vitamin supplements. Of the normal females within age range 60 — 77,
67% consumed vitamin supplements only, and 33% consumed both medication and
vitamin supplements. Of the secondary male test subjects within age range 60 — 77,
50% consumed medication only, 25% consumed vitamin and supplements only, and
25% consumed both medication and vitamin supplements. Of the secondary female test
subjects within age range 60 — 77, 27% consumed vitamin supplements only, 64%
consumed both medication and vitamin supplements, and 9% consumed neither

medication nor vitamin supplements. (Figure 90)

 

Normal and Secondary Test Subject:
Solid Oral Medication and Vitamin Supplement
Combination Consumption - Age Range 60 - 77

a:

  
 
  
  
 
 

“ I Normal Male 77
j I Nomnl Fermle

i E] Secondary Male
l

Test Subject, %
8

LESecondary Female

10' 1'
0
= m em 0
«- =._.--
2% 58 gas 8
8" E83 «SE 2
as 5225 2'52
o "D. 'U D.
2 >2. O'Ug.

Medication and Vitamin Supplement
Combination

 

 

;

 

Figure 90 — Normal and Secondary Test Subject: Solid Oral Medication and Vitamin
Supplement Combination Consumption - Age Range 60 — 77

124

Of the normal male test subjects within age range 77+, 50% consumed vitamin

supplements only, and 50% consumed both medication and vitamin supplements. Of the

normal females within age range 77+, 100% consumed both medication and vitamin

supplements. Of the secondary male test subjects within age range 77+, 100%

consumed both vitamin and supplements only. Of the secondary female test subjects

within age range 77+, 14% consumed medications only, and 86% consumed both

medication and vitamin supplements. (Figure 91)

 

Test Subject, %

 

   
 
 

Normal and Secondary Test Subject:
Solid Oral Medication and Vitamin Supplement
Combination Consumption - Age Range 77+

i D Secondary Male
LE1 Secondary Fermle

 

s a =53 a
'=>‘ ED 250 O
8" EEZ.‘ «SE Z
._5 «:0 2‘0
*7 =38 11>:
0 >9. O'Un.
2 :r 25:

m m

Medication and Vitamin Suniement
Combination

 

 

Figure 91 — Normal and Secondary Test Subject: Solid Oral Medication and Vitamin

Supplement Combination Consumption - Age Range 7 7+

125

Normal Test Subject Medication Consumption Quantities per Age Range
Of the normal male test subjects within age range 21 — 45, 96% did not consume

medication, and 4% consumed 4 medication doses, on a daily basis. Of the normal
females within age range 21 — 45, 86% did not consume medication, and 14%
consumed 1 medication dose, on a daily basis. Of the secondary male test subjects
within age range 21 — 45, 50% did not consume medication, and 50% consumed 2
medication doses on a daily basis. Of the secondary female test subjects within age
range 21 — 45, 50% consumed 7 medications doses, and 50% consumed 10 or more

medication doses, on a daily basis. (Figure 92)

 

Normal and Secondary Test Subject:
Solid Oral Daily Medication Use - Age Range 21 - 45

 

\° —
9

5 I Nonml Male

’3' "- I Noml Fennle

:1

2'} El Secondary Male

U)

: D Secondary Femali

 

012345678910+
Soild Oral Medication Quantity

 

 

 

Figure 92 — Normal and Secondary Test Subject: Solid Oral Daily Medication Use -
Age Range 21 — 45

126

Of the normal male test subjects within age range 46 — 60, 100% did not
consume any medications. Of the normal females within age range 46 — 60, 50% did not
consume any medications, 25% consumed 1 medication dose, and 25% consumed 4
does of medication, on a daily basis. Of the secondary male test subjects within age
range 46 — 60, 20% consumed 1 medication dose, 20% consumed 2 medication doses,
20% consumed 4 medication doses, 20% consumed 8 medication doses, and 20%
consumed 9 medication doses, on a daily basis. Of the secondary female test subjects
within age range 46 — 60, 20% did not consume any medications, 7% consumed 1
medication dose, 13% consumed 3 medication doses, 20% consumed 4 medication
doses, 7% consumed 5 medication doses, 7% consumed 9 medication doses, and 27%

consumed 10 or more medications, on a daily basis. (Figure 93)

 

Normal and Secondary Test Subject:
Solid Oral Daily Medication Use - Age Range 46 - 60

‘i 531le Male
1 I Nonml Female
1! E1 Secondary Male

Test Subject, %

 

l D Secondary Fermle

 

2 3 4 5 6 7 8 9 10+
Solid Oral Medication Quantity

 

 

 

Figure 93 — Normal and Secondary Test Subject: Solid Oral Daily Medication Use -
Age Range 46 — 60

127

Of the normal male test subjects within age range 60 — 77, 100% consumed 10
or more medications on a daily basis. Of the normal females within age range 60 — 77,
67% did not consume any medications, and 33% consumed 9 medication doses, on a
daily basis. Of the secondary male test subjects within age range 60 - 77, 25% did not
consume any medications, 25% consumed 7 medication doses, and 50% consumed 10
or more medication doses, on a daily basis. Of the secondary female test subjects within
age range 60 — 77, 36% did not consume any medications, 9% consumed 2 medication
doses, 18% consumed 4 medication doses, 9% consumed 5 medication doses, 9%
consumed 9 medication doses, and 18% consumed 10 or more medications, on a daily

basis. (Figure 94)

 

, Normal and Secondary Test Subject:
Solid Oral Daily Medication Usage - Age Range 60 - 77

 
    
  
 
    

Nonml Male

Normal Fermle

  

Secondary Male

Test Subject, %

Secondary Ferrale

 

012345678910+
Solid Oral thication Quantity

 

 

 

 

Figure 94 — Normal and Secondary Test Subject: Solid Oral Daily Medication Use -
Age Range 60 — 77

128

Of the normal male test subjects within age range 77+, 50% did not consume

any medications and 50% consumed 2 medication closes, on a daily basis. Of the normal

females within age range 77+, 100% consumed 6 medication doses, on a daily basis. Of

the secondary male test subjects within age range 77+, 50% consumed 3 medication

doses and 50% consumed 10 or more medication doses, on a daily basis. Of the

secondary female test subjects within age range 77+, 14% consumed 1 medication dose,

14% consumed 4 medication doses, 14% consumed 6 medication doses, 14% consumed

9 medication doses, and 29% consumed 10 or more medications, on a daily basis.

(Figure 95)

 

Test Subject, %

 

Solid Oral Daily Medication Usage - Age Range 77+

 

Normal and Secondary Test Subject:

(a Normal Male
} I Normal Female

 

 

2 3 4 5 6 7 8 9 10+
Solid Oral Medication Quantity

 

 

Figure 95 — Normal and Secondary Test Subject: Solid Oral Daily Medication Use -

Age Range 77+

129

Vitamin Supplement Usage Quantities per Age Range
Of the normal male test subjects within age range 21 — 45, 61% did not consume

any vitamin supplements, 30% consumed 1 vitamin supplement dose, 4% consumed 3
vitamin supplement doses, and 4% consumed 5 vitamin supplement doses, on a daily
basis. Of the normal females within age range 21 — 45, 50% did not consume any
vitamin supplements, 21% consumed l vitamin supplement dose, 7% consumed 2
vitamin supplement doses, 14% consumed 3 vitamin supplement doses, and 7%
consumed 7 vitamin supplement doses, on a daily basis. Of the secondary male test
subjects within age range 21 — 45, 50% did not consume any vitamin supplements and
50% consumed 3 vitamin supplement doses, on a daily basis. Of the secondary female
test subjects within age range 21 — 45, 25% did not consume any vitamin supplements,
50% consumed lvitamin supplement dose, and 25% consumed 7 vitamin supplement

doses, on a daily basis. (Figure 96)

 

Normal and Secondary Test Subject:
Solid Oral Daily Vitamin Supplement Consumption -
Age Range 21 - 45

 
 
 
  

{. 11‘] Nomal Male 7

 

.\°
.: 70 ‘ ‘
g 237 ‘-. ‘INorrmlFemale
5 40 CI Secondary Male
5 33 Dfiacondary Femalej
10 '~
0 ,

01234567891045
Solid Oral Vitamin Supflement Quantity

 

 

 

Figure 96 — Normal and Secondary Test Subject: Solid Oral Daily Vitamin
Supplemental Consumption - Age Range 21 - 45

130

Of the normal male test subjects within age range 46 — 60, 50% did not consume
any vitamin supplements and 50% consumed 5 vitamin supplement doses, on a daily
basis. Of the normal females within age range 46 — 60, 50% did not consume any
vitamin supplements, 21% consumed l vitamin supplement dose, and 25% consumed 3
vitamin supplement doses, on a daily basis. Of the secondary male test subjects within
age range 46 — 60, 60% did not consume any vitamin supplements, 20% consumed 1
vitamin supplement dose, and 20% consumed 3 vitamin supplement doses, on a daily
basis. Of the secondary female test subjects within age range 46 — 60, 47% did not
consume any vitamin supplements, 20% consumed lvitmain supplement dose, 7%
consumed 2 vitamin supplement doses, 13% consumed 3 vitamin supplement doses, 7%
consumed 5 vitamin supplement doses, and 7% consumed 6 vitamin supplement doses,

on a daily basis. (Figure 97)

 

Normal and Secondary Test Subject:
Soild Oral Daily Vitamin Supplement Consumption -
Age Range 46 - 60

   
 
   
 
 
 

Ed 13mm] Male
I Nor-rml Fermle
Cl Secondary Male

 

DSecondary Fermle

 

Test Subject,%
8538 88888 888

012345678910+

 

Solid Oral Vitamin Supplement Quantity

L_.___n

Figure 97 — Normal and Secondary Test Subject: Solid Oral Daily Vitamin
Supplemental Consumption - Age Range 46 — 60

 

 

131

Of the normal male test subjects within age range 60 — 77, 100% consumed 3
vitamin supplement doses, on a daily basis. Of the normal females within age range
60 — 77, 33% consumed l vitamin supplement dose, 33% consumed 4 vitamin
supplement doses, and 33% consumed 6 vitamin supplement doses, on a daily basis. Of
the secondary male test subjects within age range 60 — 77, 50% did not consume any
vitamin supplements, 25% consumed 4 vitamin supplement doses, and 25% consumed
3 vitamin supplement closes, on a daily basis. Of the secondary female test subjects
within age range 60 — 77, 9% did not consume any vitamin supplements, 45%
consumed 1 vitamin supplement dose, 9% consumed 2 vitamin supplement doses, 9%
consumed 3 vitamin supplement doses, 18% consumed 4 vitamin supplement doses,

and 9% consumed 8 medication doses, on a daily basis. (Figure 98)

l— _ _______

 

"l
j Nornurl and Secondary Test Subject:
1 Solid Oral Daily Vitamin Supplement Consumption -
Age Range 60 - 77

 

 

 

 

i I Normal Male 1

I Normal Fermle

 

D Secondary Male
it] Secondary Female 1.

1

Test Subject, %

 

 

l

 

012345678910+
Solid Oral Vitamin Supflement Quantity

 

 

Figure 98 — Normal and Secondary Test Subject: Solid Oral Daily Vitamin
Supplemental Consumption - Age Range 60 —- 77

132

Of the normal male test subjects within age range 77+, 50% consumed 1 vitamin
supplement dose and 50% consumed 2 vitamin supplement doses, on a daily basis. Of
the normal females within age range 77+, 100% consumed 5 vitamin supplement doses,
on a daily basis. Of the secondary male test subjects within age range 77+, 50%
consumed 1 vitamin supplement dose and 50% consumed 4 vitamin supplement doses,
on a daily basis. Of the secondary female test subjects within age range 77+, 14% did
not consume any vitamin supplements, 57% consumed lmedication dose, and 29%

consumed 2 vitamin supplements, on a daily basis. (Figure 99)

 

Normal and Secondary Test Subject:
Solid Oral Daily Vitamin Supplement Consumption -
Age Range 77+

 
   
 
    
 
  

  

i I Normal Male
i I Nomal Female

i D Secondary Male

Test Subject, %
LII
o

i 121 Secondary Female

3 4 5 6 7 8 9 10+
Solid Oral Vitamin Supflement Quantity

 

 

g

Figure 99 — Normal and Secondary Test Subject: Solid Oral Daily Vitamin
Supplemental Consumption - Age Range 77+

133

Section 3: Normal and Secondary Test Subject Medication/Vitamin Supplement
Packaging Use
Of the normal male test subjects within age range 21 — 45, 4% use paperboard

cartons with blister sheets, 65% use bottles with child-resistant closures, and 9% use
bottles without child-resistant closures. Of the normal females within age range 21 — 45,
14% use paperboard cartons with blister sheets, 36% use bottles with child-resistant
closures, and 29% use bottles without child-resistant closures. Of the secondary male
test subjects within age range 21 — 45, 50% use bottles with child-resistant closures, and
50% use bottles without child-resistant closures. Of the secondary female test subjects
within age range 21 — 45, 25% use bottles with child-resistant closures, and 75% use

bottles without child-resistant closures. (Figure 100)

 

Normal and Secondary Test Subject:
Solid Oral Medication/Vitamin Supplement Package Use -
Age Range 21 - 45

 

\°

° \

,3 I Nonml Male

2% 1 I Nomal Female

2 | E1 Secondary Male
fl k 13 Secondary Female

 

Paperboard Bottle with Bottle Other

Carton with Child- without
Blister Sheets Resistant Child-
Closure Resistant
Closure
Test Subject Response

 

 

 

Figure 100 — Normal and Secondary Test Subject: Solid Oral Daily MedicationNitamin
Supplement Package Use - Age Range 21 - 45

134

Of the normal male test subjects within age range 46 — 60, 50% use bottles with
child-resistant closures, and 50% use other kinds of medication/vitamin supplement
packaging. Of the normal females within age range 46 — 60, 25% use paperboard
cartons with blister sheets, 50% use bottles with child-resistant closures, and 25% use
bottles without child-resistant closures. Of the secondary male test subjects within age
range 46 — 60, 40% use bottles with child-resistant closures, 40% use bottles without
child-resistant closures, and 20% use other kinds of medication/vitamin supplement
packaging. Of the secondary female test subjects within age range 46 — 60, 7% use
paperboard cartons with blister sheets, 40% use bottles with child-resistant closures,
27% use bottles without child-resistant closures, and 7% use other kinds of

medication/vitamin supplement packaging. (Figure 101)

 

Normal and Secondary Test Subject:
Solid Oral Medication/Vitamin Supplement Package Use -
Age Range 46 - 60

 

\°

6

g I Nonml Male

'5' I Nonml Fermle

(.2 E1 Secondary Male
S D Secondary Fermle

 

 

 

 

Paperboard Bottle with Bottle Other

 

 

Carton with Child- without
Blister Res istant Child-
Sheets Clos ure Res istant

Clos ure
Test Subject Response

 

Figure 101 — Normal and Secondary Test Subject: Solid Oral Daily Medication/Vitamin
Supplement Package Use - Age Range 46 - 60

135

Of the normal male test subjects within age range 60 — 77, 100% use bottles
with child-resistant closures. Of the normal females within age range 60 — 77, 67% use
bottles without child-resistant closures. Of the secondary male test subjects within age
range 60 — 77, 50% use bottles with child-resistant closures and 25% use other kinds of
medication/vitamin supplement packaging. Of the secondary female test subjects within
age range 60 — 77, 9% use paperboard cartons with blister sheets, 45% use bottles with
child-resistant closures, and 27% use bottles without child-resistant closures.

(Figure 102)

 

Normal and Secondary Test Subject:
Solid Oral Medication/Vitamin Supplement Package Use -
Age Range 60 - 77

    

 

\e 80
° #—
‘3 23 “1% I Normal Male
2;?" 50 ‘ I Nomral Female
2 :8 in Secondary Male
; 20 i 121 Secondary Female
10 #1—
0 _
Paperboard Bottle with Bottle Other
Carton with Child- without
Blister Sheets Resistant Child-
Closure Resistant
Closure
Test Subject Response

 

 

 

Figure 102 — Normal and Secondary Test Subject: Solid Oral Daily Medication/Vitamin
Supplement Package Use - Age Range 60 — 77

136

Of the normal male test subjects within age range 77+, 100% use bottles without
child-resistant closures. Of the normal females within age range 77+, 100% use bottles
with child-resistant closures. Of the secondary male test subjects within age range 77+,
50% use paperboard cartons with blister sheets, and 50% use bottles with child-resistant
closures. Of the secondary female test subjects within age range 77+, 14% use
paperboard cartons with blister sheets, 29% use bottles with child-resistant closures,
29% use bottles without child-resistant closures, and 29% use bottles without child-

resistant closures. (Figure 103)

 

Normal and Secondary Test Subject:
Solid Oral Medication/Vitamin Supplement Package Use -

 

 

 

Age Range 77+
100
90
:3 ,___
‘3’ 60 l I Nomal Male
E 50 l I Normal Female
to 40 r
a 30 t D Secondary Male
0 r
l" 20 1 1:] Secondary Female
10
0
Paperboard Bottle with Bottle Other
Carton with Child- without
Blister Resistant Child-
Sheets Closure Resistant
Closure
Test Subject Response

 

%

Figure 103 — Normal and Secondary Test Subject: Solid Oral Daily MedicationNitamin
Supplement Package Use - Age Range 77+

137

Of the normal male test subjects within age range 21 — 45, 9% use both
paperboard cartons with blister sheets and bottles with child-resistant closures, 9% use
paperboard cartons with blister sheets and bottles without child—resistant closures, 4%
use bottles with and without child-resistant closures. Of the normal females within age
range 21 — 45, 21% use paperboard cartons with blister sheets and bottles without child-
resistant closures, 21% use paperboard cartons with blister sheets and bottles without
child-resistant closures and 7% use bottles with and without child-resistant closures. Of
the secondary female test subjects within age range 21 — 45, 50% use bottles without

child-resistant closures. (Figure 104)

 

Normal and Secondary Test Subject:
Solid Oral Medication/Vitamin Supplement Combination
Package Use - Age Range 21 - 45

    

 

100 _.
m ,
.\° 80 . d
g 70 f INomnl Male
.0 60
3 50 INomnalFemale
' 40
g 30 = 121 Secondary Male
0 1
[- 20 ClSecond Female
,3 gm MM

Paperboard Paperboard Bottlewith Paperboard
Carton with Carton with and without Carton with

Blister Blister Child- Blister
Sheets and Sheets and Resistant Sheets and
Bottle with Bottle with Closure Bottle

Cnild- and without without

Resistant Child- Child-
Closure Resistant Resistant
Test Subject Response

 

 

 

Figure 104 — Normal and Secondary Test Subject: Solid Oral Daily Medication/Vitamin
Supplement Combination Package Use - Age Range 21 — 45

138

Of the normal females within age range 46 — 60, 25% use paperboard cartons
with blister sheets and bottles with child-resistant closures and 25% use bottles with and
without child-resistant closures. Of the secondary female test subjects within age range
46 — 60, 13% use paperboard cartons with blister sheets and bottles with child-resistant

closures and 7% use bottles with and without child-resistant closures. (Figure 105)

 

Normal and Secondary Test Subject:
Solid Oral Medication/Vitamin Supplement Combination
Package Use - Age Range 46 - 60

CI Normal Male
I Nor-rm] Fermle

CI Secondary Male

Test Subject, %

 

El Secondary Femab’

 

Paperboard Paperboard Bottle with Paperboard
Carton with Carton with and without Carton with

 

Blister Blister Child- Blister
Sheets and Sheets and Resistant Sheets and
Bottle with Bottle with Closure Bottle

Child- and without without

Resistant Child- Child-
Closure Resistant Resistant
Closure Closure
Test Subject Response

 

 

Figure 105 — Normal and Secondary Test Subject: Solid Oral Daily MedicationNitamin
Supplement Combination Package Use - Age Range 46 —— 60

139

Of the normal males within age range 60 — 77, 100% use paperboard cartons
with blister sheets and bottles without child-resistant closures. Of the normal females
within age range 60 — 77, 33% use paperboard cartons with blister sheets and bottles
with child-resistant closures. Of the secondary female test subjects within age range
60 — 77, 9% use paperboard cartons with blister sheets and bottles with child-resistant

closures, and 9% use bottles with and without child-resistant closures. (Figure 106)

 

Normal and Secondary Test Subject:
Solid Oral Medication/Vitamin Supplement Combination
Package Use - Age Range 60 - 77

  
  
   

I Normal Male

I No ma] Female

  

  

El Secondary Male

Test Subject, %
3

    
   

. , El Secondary Fermle
Paperboard Paperboard Bottle with Paperboard
Carton with Carton with and without Carton with

Blister Blister Child- Blister
Sheets and Sheets and Resistant Sheets and
Bottle with Bottle with Closure Bottle

 

Child- and without without
Resistant Child- Child-
Closure Resistant Resistant
Closure Closure
Test Subject Response

 

L

Figure 106 — Normal and Secondary Test Subject: Solid Oral Daily MedicationNitamin
Supplement Combination Package Use - Age Range 60 - 77

140

None of the normal males within age range 77+ used combinations of packaging

for their medications/vitamin supplements. (Figure 107)

 

Normal and Secondary Test Subject:
Solid Oral Medication/Vitamin Supplement Combination
Package Use - Age Range 77+

  

l I Nor-rml Male

L‘ I Norrml Fermle

l E! Secondary Male
l I] Secondary Fermle

  

Test Subject, %
‘6

Paperboard Paperboard Bottle with Paperboard
Carton with Carton with and without Carton with
Blister Blister Child- Blister
Sheets and Sheets and Resistant Sheets and

Bottle with Bottle with Closure Bottle

 

Grild- and without without
Resistant Child- Child-
Closure Resistant Resistant
Closure Closure
Test Subject Response

 

 

Figure 107 — Normal and Secondary Test Subject: Solid Oral Daily MedicationNitamin
Supplement Combination Package Use - Age Range 77+

141

Section 4: Normal and Secondary Test Subject Child-Resistant Medication/Vitamin
Supplement Packaging Ease of Use

Of the normal male test subjects within age range 21 — 45, 22% said child-
resistant packaging ease of use was very easy, 52% said child—resistant packaging ease
of use was about right, and 26% thought child-resistant packaging ease of use was
somewhat difficult. Of the normal females within age range 21 — 45, 14% said child-
resistant packaging ease of use was very easy, 57% said child-resistant packaging ease
of use was about right, and 29% said child-resistant packaging ease of use was
somewhat difficult. Of the secondary male test subjects within age range 21 — 45, 50%
said child-resistant packaging ease of use was very easy and 50% said child-resistant
packaging ease of use was somewhat difficult. Of the secondary female test subjects
within age range 21 — 45, 25% said child-resistant packaging ease of use was very easy,

and 75% said child-resistant packaging ease of use was somewhat difficult. (Figure

108)

 

Normal and Secondary Test Subject:
Child-Resistant Package Ease of Use -
Age Range 21 - 45

 
  

    
 

g 80 __
.5 70 , I Nomral Male

fi' 60 I Normal Female
= 5" m a? »

2 :8 El Secondary Male
[3 20

D Secondary Female

Very Easy About Right Somewhat Very
Diflicult Difficult

Test Subject Response

 

 

 

Figure 108 — Normal and Secondary Test Subject: Child-Resistant Package Ease of Use
- Age Range 21 —45

142

Of the normal male test subjects within age range 46 - 60, 50% said child-
resistant packaging ease of use was very easy, and 50% said child-resistant packaging
ease of use was somewhat difficult. Of the normal females within age range 46 — 50,
25% said child—resistant packaging ease of use was about right, and 75% said child-
resistant packaging ease of use was somewhat difficult. Of the secondary male test
subjects within age range 46 — 60, 20% said child-resistant packaging ease of use was
very easy, 40% said child-resistant packaging ease of use was about right, and 40% said
child- resistant packaging ease of use was somewhat difficult. Of the secondary female
test subjects within age range 21 —— 45, 13% said child-resistant packaging ease of use
was very easy, 13% said child-resistant packaging ease of use was about right, 40% said
child-resistant packaging ease of use was somewhat difficult, and 33% said child-

resistant packaging ease of use was very difficult. (Figure 109)

 

Normal and Secondary Test Subject:
Child-Resistantant Package Ease of Use -
Age Range 46 - 60

j Nomal Male

I Norrml Fermle

    
 

, ,, l
' Q l [3 Secondary Male

Q i? Secondary Fermle

  

Test Subject, %
LII
O

Very
Difficult Difficult

Test Subject Response

 

 

 

Figure 109 — Normal and Secondary Test Subject: Child-Resistant Package Ease of Use
- Age Range 46 —- 60

143

Of the normal male test subjects within age range 60 — 77, 100% said child-
resistant packaging ease of use was very easy. Of the normal females within age range
60 - 77, 33% said child-resistant packaging ease of use was about right, and 67% said
child-resistant packaging ease of use was somewhat difficult. Of the secondary male
test subjects within age range 60 — 77, 50% said child—resistant packaging ease of use
was about right, and 50% said child-resistant packaging ease of use was somewhat
difficult. Of the secondary female test subjects within age range 60 — 77, 9% said child-
resistant packaging ease of use was very easy, 18% said child-resistant packaging ease
of use was about right, 36% said child-resistant packaging ease of use was somewhat
difficult, and 29% said child-resistant packaging ease of use was very difficult. (Figure

110)

 

T Normal and Secondary Test Subject:
Child-Resistant Package Ease of Use -
Age Range 60 - 77

Roma] Mali *1

    
 

I Norrml Female

   

30 " ' :- ‘ D Secondary Male
20 j g E El Secondary Female

 

Test Subject, %
ill
o

Very Easy About Right Sorrrewhat Very
Difficult Difiicult

 

 

Test Subject Response J

 

Figure 110 — Normal and Secondary Test Subject: Child-Resistant Package Ease of Use
- Age Range 60 - 77

144

Of the normal male test subjects within age range 77+, 100% said child-resistant
packaging ease of use was somewhat difficult. Of the normal females within age range
77+, 100% said child-resistant packaging ease of use was about right. Of the secondary
male test subjects within age range 77+, 50% said child-resistant packaging ease of use
was about right, and 50% said child-resistant packaging ease of use was somewhat
difficult. Of the secondary female test subjects within age range 77+, 43% said child—
resistant packaging ease of use was about right, 29% said child-resistant packaging ease
of use was somewhat difficult, and 29% said child-resistant packaging ease of use was

very difficult. (Figure 111)

 

Normal and Secondary Test Subject:
Child-Resistant Package Ease of Use -
Age Range 77+

I Nonml Male

I Normal Female

Test Subject, %

D Secondary Male

  

Very Easy About Right Somewhat Very
Difficult Difficult

Test Subject Response

 

 

 

Figure 111 - Normal and Secondary Test Subject: Child—Resistant Package Ease of Use
- Age Range 77+

145

Section 5: Normal and Secondary Test Subject Medication/Vitamin Supplement Solid
Oral Organizer Use

Of the test subjects within age range 21 — 45, 13% of normal males, 21% of
normal females, 50% of secondary males, and 25% of secondary females, use pill
organizers. Of the test subjects within age range 21 — 45, 87% of normal males, 79% of
normal females, 50% of secondary males, and 75% of secondary females, do not use

pill organizers. (See Figure 112)

 

Normal and Secondary Test Subject:
Pill Organizer/Dispenser Use - Age Range 21 - 45

‘; NorrmI Male

" l I Noml Fermle

   

Test Subject, %
‘6

l [:1 Secondary Male
% ‘ D Secondary Female

 

Test Subject Response

 

 

 

Figure 112 — Normal and Secondary Test Subject: Pill Organizer Use -

Age Range 21 — 45

146

Of the test subjects within age range 46 — 60, 25% of normal females, 40% of
secondary males, and 67% of secondary females, use pill organizers. Of the test subjects
within age range 21 — 45, 100% of normal males, 75% of normal females, 60% of

secondary males, and 33% of secondary females, do not use pill organizers. (Figure

113)

 

Normal and Secondary Test Subject: l
Pill Organizer/Dispenser Use - e Range 46 - 60

   
 
 
 
  

100 , m, ,
m : ., .1. lg:
80 , _. .- t

,, tg leormalMale

l I Normal Female

Test Subject, °/o
LII
O

 

3(0) ' El Secondary Male
20 El Secondary Fermle
10
0
Yes No
Test Subject Response

 

 

 

Figure 113 - Normal and Secondary Test Subject: Pill Organizer Use -
Age Range 46 - 60

147

Of the test subjects within age range 60 — 77, 100% of normal males, 67% of
normal females, 75% of secondary males, and 55% of secondary females use pill
organizers. Of the test subjects within age range 60 — 77, 33% of normal females, 25%

of secondary males, and 45% of secondary females, do not use pill organizers. (Figure

114)

 

Normal and Secondary Test Subject:
Pill Organ'mer/Dispenser Use - Age Range 60 - 77

    

Wfi
a l I Non-ml Male

l I Nonml Fermle

Test Subject, %
8

 

30 C1 Secondary Male
20 , ll] Secondary Female
10
0 .
Yes No
Test Subject Response

 

 

 

Figure 114 — Normal and Secondary Test Subject: Pill Organizer Use -
Age Range 60 — 77

148

Of the test subjects within age range 77+, 50% of normal males, 50% of
secondary males, and 43% of secondary females, use pill organizers. Of the test subjects
within age range 77+, 50% of normal males, 100% of normal females, 50% of
secondary males, and 57% of secondary females, do not use pill organizers.

(Figure 115)

 

Normal and Secondary Test Subject:
Pill Organizer/Dispenser Use - Age Range 77+

   
 
 

I l Nomral Male

I Normal Fermle

l E! Secondary Male
[D Secondary Fermle

Test Subject, %

 

Test Subject Response

 

 

 

Figure 115 — Normal and Secondary Test Subject: Pill Organizer Use - Age Range 77+

149

Section 6: Normal and Secondary Test Subject Medication/Vitamin Supplement Solid
Oral Organizer Preference

Of the test subjects within age range 21 — 45, 30% of normal males, 43% of
normal females, and 50% of secondary males prefer daily child-resistant pill organizers.
Of the test subjects within age range 21 — 45, 7% of normal females and 50% of
secondary males prefer daily pill organizers that are not child-resistant. Of the test
subjects within age range 21 — 45, 26% of normal males, and 21% of normal females
prefer multi-dose per day child-resistant pill organizers. Of the test subjects within age
range 21 — 45, 4% of normal males, 7% of normal females, and 100% of secondary
females prefer multi dose per day pill organizers that are not child-resistant. Of the test
subjects within age range 21 — 45, 39% of normal males, and 21% of normal females

prefer to not use any kind of pill organizer. (Figure 116)

 

Normal and Secondary Test Subject:
Pill Organizer/DispenserUse/Preference -
Age Range 21 - 45

    

: El Normal Male

: I Nonml Fermle

Test Subject, %
‘6

l‘ 13 Secondary Male
113 Secondary Fermle

Daily - Daily - Not Multi Dose Multi Dose None
Child- Child- per Day - per Day -
Resistant Resistant Child- Not Child-
Resistant Resistant

Test Subject Response

 

 

 

Figure 116 — Normal and Secondary Test Subject: Pill Organizer/Dispenser
Use/Preference - Age Range 21 - 45

 

4

150

Of the test subjects within age range 46 — 60, 25% of normal females, 20% of
secondary males, and 13% of secondary females prefer daily child-resistant pill
organizers. Of the test subjects within age range 46 — 60, 60% of secondary males, and
20% of secondary females prefer daily pill organizers that are not child-resistant. Of the
test subjects within age range 46 - 60, 50% of normal males, 50% of normal females,
and 7% of secondary females prefer multi-dose per day child—resistant pill organizers.
Of the test subjects within age range 46 — 60, 53% of secondary females prefer multi
dose per day pill organizers that are not child-resistant. 0f the test subjects within age
range 46 — 60, 50% of normal males, 25% of normal females, 20% of secondary males,

and 7% secondary females prefer to not use any kind of pill organizer. (See Figure 117)

 

Normal and Secondary Test Subject:
1 Pill OrgaizerfDispenser Use/Preference -
Age Range 46 - 60

    

I Nonml Male T
I Nonml Ferrale

Test Subject, %
Us
0

0 Secondary Male

 

D Secondary Female

Daily - Daily - Not Multi Dose Multi Dose None
Child- Child- per Day - per Day -
Res istant Resistant Child- Not Child-
Res istant Res istant

Test Subject Response

 

 

 

Figure 117 — Normal and Secondary Test Subject: Pill Organizer/Dispenser
Use/Preference - Age Range 46 — 60

151

Of the test subjects within age range 60 — 77, 25% of secondary males and 9%
of secondary females prefer daily child-resistant pill organizers. Of the test subjects
within age range 60 -— 77, 25% of secondary males and 18% of secondary females prefer
daily pill organizers that are not child-resistant. Of the test subjects within age range
60 — 77, 100% of normal males prefer multi-dose per day child-resistant pill organizers.
Of the test subjects within age range 60 — 77, 100% of normal females, 25% of
secondary males, and 45% of secondary females prefer multi dose per day pill
organizers that are not child-resistant. Of the test subjects within age range 60 — 77,

50% of normal males, 25% of secondary males and 27% of secondary females prefer

not to use any kind of pill organizer. (Figure 118)

 

Normal and Secondary Test Subject:
Pill OrganizedDispenser Use/Preference -
Age Range 60 - 77

Test Subject, %

 

Daily - Daily - Not Multi Dose Multi Dose None
Child- Child- per Day - per Day -
Resistant Resistant Child- Not Child-
Resistant Resistant

 

Test Subject Response

 

 

 

Figure 118 - Normal and Secondary Test Subject: Pill Organizer/Dispenser
Use/Preference - Age Range 60 — 77

152

Of the test subjects within age range 77+, 50% of secondary males and 14% of
secondary females prefer daily pill organizers that are not child-resistant. Of the test
subjects within age range 77+, 50% of normal males and 57% of secondary females
preferred multi dose per day pill organizers that are not child-resistant. Of the test
subjects within age range 77+, 50% of normal males, 100% of normal females, 50% of
secondary males, and 29% of secondary females prefer to not use any kind of pill

organizer. (Figure 119)

 

Normal and Secondary Test Subject:
Pill Organ’wer/Dispenser Use/Preference -
Age Range 77+

I Nomnl Male
‘ g lINormal Female
gas in Secondary Male

ED Secondary Femle

   

 

Test Subject, %
LII
O

 

Daily - Daily - Not Multi Dose Multi Dose None
Child- Child- per Day - per Day -
Resistant Resistant Child- Not Child-
Resistant Resistant

Test Subject Res ponse

 

 

 

Figure 119 - Normal and Secondary Test Subject: Pill Organizer/Dispenser
Use/Preference - Age Range 77+

153

Section 7: Normal and Secondary Test Subject New Package Questions

Package Method of Use was Easy to Understand per Age Range

Of the test subjects within age range 21 — 45, 57% of normal males, 50% of

normal females, 100% of secondary males, and 75% of secondary females strongly

agreed that the package method of use was easy to understand. Of the test subjects

within age range 21 —- 45, 43% of normal males, 50% of normal females, and 25% of

secondary females agreed that the package method of use was easy to understand. Of

the test subjects within age range 21 — 45, 57% of normal males, 50% of normal

females, 100% of secondary males, and 75% of secondary females strongly agreed that

the package method of use was easy to understand. (Figure 120)

 

Normal and Secondary Test Subject:
Package Method of Use was Easy to Understand -
Age Range 21 - 45

 
  
  
   

‘fl—N—ormal Male
j I Nomnl Female
1

Test Subject, %

Strongly Agree Neither Dis agree Strongly
Agree Agree Dis agree
nor

Dis agree

Test Subject Response

 

El Secondary Male
1 D Secondflfermle

 

 

Figure 120 —- Normal and Secondary Test Subject: Package Method of Use was Easy to

Understand - Age Range 21 — 45

154

Of the test subjects within age range 46 — 60, 100% of normal males, 100% of
normal females, 60% of secondary males, and 5 3% of secondary females strongly
agreed that the package method of use was easy to understand. Of the test subjects
within age range 46 — 60, 20% of secondary males and 20% of secondary females
agreed that the package method of use was easy to understand. Of the test subjects
within age range 46 — 60, 20% of secondary males and 13% of secondary females
neither agreed nor disagreed that the package method of use was easy to understand. Of
the test subjects within age range 46 -— 60, 7% of secondary females disagreed that the
package method of use was easy to understand. Of the test subjects within age range
46 — 60, 7% of secondary females strongly disagreed that the package method of use

was easy to understand. (Figure 121)

 

Normal and Secondary Test Subject:
Package Method of Use was Easy to Understand -
Age Range 46 - 60

     
 

  

°\° 80 , —————# —~
4 70 ‘/ Nor-rml Male
0 60 ‘
fi' 50 :17; 1 I Nom'al Fermle
‘25 :3 $3,: ‘ El Secondary Male
5 20 g; ' Cl Secondary Female
10 pg
0 . .
Strongly Agree Neither Disagree Strongly
Agree Agree Disagree
nor
Disagree
Test Subject Response

 

 

 

Figure 121 — Normal and Secondary Test Subject: Package Method of Use was Easy to
Understand - Age Range 46 — 60

155

Of the test subjects within age range 60 — 77, 50% of secondary males and 18%
of secondary females strongly agreed that the package method of use was easy to
understand. Of the test subjects within age range 60 — 77, 100% of normal males, 67%
of normal females, 50% of secondary males, and 73% of secondary females agreed that
the package method of use was easy to understand. Of the test subjects within age range
60 — 77, 9% of secondary females neither agreed nor disagreed that the package method
of use was easy to understand. Of the test subjects within age range 60 — 77, 33% of

normal females disagreed that the package method of use was easy to understand.

 

(Figure 122)
Normal and Secondary Test Subject:
Package Method of Use was Easy to Understand -
Age Range 60 - 77
100 .5
90 -.=

 
   
   

Noml Male

1 I Nomral Fermle

Test Subject, %
8

 

3o 5 1 El Secondary Male
3 i L [:1 Secondary Female

0 " .......... -_‘-.-
Strongly Agree Neither Disagree Strongly
Agree Agree Disagree
nor
Disagree
Test Subject Response

 

 

 

Figure 122 — Normal and Secondary Test Subject: Package Method of Use was Easy to
Understand - Age Range 60 — 77

156

Of the test subjects within age range 77+, 50% of secondary males and 14% of
secondary females strongly agreed that the package method of use was easy to
understand. Of the test subjects within age range 77+, 50% of secondary males and 71%
of secondary females agreed that the package method of use was easy to understand. Of
the test subjects within age range 77+, 50% of normal males, 100% of normal females,
and 14% of secondary females neither agreed nor disagreed that the package method of
use was easy to understand. Of the test subjects within age range 77+, 50% of normal

males disagreed that the package method of use was easy to understand. (Figure 123)

 

Normal and Secondary Test Subject:
Package Method of Use was Easy to Understand Age

Ell Nomi Male

I Normal Female

[3 Secondary Male

El Secondary Fermi:

Test Subject, %

 

 

 

Strongly Agree Neither Disagree Strongly
Agree Agree Disagree
nor
Disagree

Test Subject Response

 

 

 

Figure 123 — Normal and Secondary Test Subject: Package Method of Use was Easy to
Understand - Age Range 77+

157

The Feel of the Handle is Comfortable per Age Range
Of the test subjects within age range 21 — 45, 9% of normal males, 100% of

secondary males, and 25% of secondary females strongly agreed that the package
handle was comfortable. Of the test subjects within age range 21 — 45, 43% of normal
males, 64% of normal females, and 25% of secondary females agreed that the package
handle was comfortable. Of the test subjects within age range 21 — 45, 9% of normal
males, 7% normal females, and 25% of secondary females neither agreed nor disagreed
that the package handle was comfortable. Of the test subjects within age range 21 — 45,
39% of normal males, 14% of normal females, and 25% of secondary females disagreed
that the package handle was comfortable. Of the test subjects within age range 21 — 45,
14% of normal females strongly disagreed that the package handle was comfortable.

(Figure 124)

 

Normal and Secondary Test Subject:
The Feel of the Handle is Comfortable -
Age Range 21 - 45

  
 

I Normal Male
.': 1 I Nonml Fermle

Test Subject, %
8

40 El Secondary Male
:8 [:1 Secondary Fermle
10
0
Strongly Agree Neither Disagree Strongly
Agree Agree Disagree
nor
Disagree
Test Subject Response

 

 

 

Figure 124 — Normal and Secondary Test Subject: The Feel of the Handle is
Comfortable - Age Range 21 — 45

158

Of the test subjects within age range 46 — 60, 50% of normal males, 25% of
normal females, 20% of secondary males, and 33% of secondary females strongly
agreed that the package handle was comfortable. Of the test subjects within age range
46 — 60, 50% of normal males, 75% of normal females, 60% of secondary males, and
13% of secondary females agreed that the package handle was comfortable. Of the test
subjects within age range 46 — 60, 13% of secondary females neither agreed nor
disagreed that the package handle was comfortable. Of the test subjects within age
range 46 — 60, 20% of males and 20% of secondary females disagreed that the package
handle was comfortable. Of the test subjects within age range 46 — 60, 20% of

secondary females strongly disagreed that the package handle was comfortable. (Figure
125)

 

Normal and Secondary Test Subject:
The Feel of the Handle is Comfortable -

Age Range 46 - 60

 
  
 
 
 
     

\e 80 , m,—
9

.5 23 ,‘ElNonml Male
E‘ 50 INorrmlFen'ale
=

9 :3 iElSecondary Male
U)

I)

[-7

‘0 Secondary Female

10
0 ...... . a
Strongly Agree Neither Disagree Strongly
Agree Agree Disagree
nor
Disagree
Test Subject Response

 

L

 

 

___J

Figure 125 - Normal and Secondary Test Subject: The Feel of the Handle is
Comfortable - Age Range 46 — 60

159

Of the test subjects within age range 60 — 77, 18% of secondary females
strongly agreed that the package handle was comfortable. Of the test subjects within age
range 60 — 77, 33% of normal females, 50% of secondary males, and 36% of secondary
females agreed that the package handle was comfortable. Of the test subjects within age
range 60 — 77, 100% of normal males neither agreed nor disagreed that the package
handle was comfortable. Of the test subjects within age range 60 — 77, 67% of normal
females, 50% of secondary males, and 27% of secondary females, disagreed that the
package handle was comfortable. Of the test subjects within age range 60 — 77, 18% of
secondary female test subjects strongly disagreed that the package handle was

comfortable. (Figure 126)

 

   

 

 

Normal and Secondary Test Subject:
The Feel of the Handle is Comfortable -
Age Range 60 - 77
100
90
\o 80 r—H—
3, 7o INonmr Male
g- g3 . INonmlFemle
IE 40 ' El Secondary Male
3 33 \1] Secondary Female
10
0 ‘ ‘ ‘ .
Strongly Agree Neither Disagree Strongly
Agree Agree Disagree
nor
Disagree
Test Subject Response

 

 

Figure 126 —— Normal and Secondary Test Subject: The Feel of the Handle is
Comfortable - Age Range 60 — 77

160

Of the test subjects within age range 77+, 9% of normal males and 50% of
secondary males strongly agreed that the package handle was comfortable. Of the test
subjects within age range 77+, 100% of normal males, 100% of normal females, 50% of
secondary males, and 57% of secondary females agreed that the package handle was
comfortable. Of the test subjects within age range 77+, 43% of secondary females

neither agreed nor disagreed that the package handle was comfortable. (Figure 127)

 

Normal and Secondary Test Subject:
The Feel of the Handle is Comfortable -
Age Range 77+

 
 
    
 
   

  

AI Nonml Male
I Nonnal Female
C] Secondary Male
LII] Secondary Female

  
 

Test Subject, %
LII
O

  

 

0 V ............. ‘ ... >4
Strongly Agree Neither Disagree Strongly
Agree Agree Disagree

nor
Disagree
Test Subject Response

 

 

Figure 127 — Normal and Secondary Test Subject: The Feel of the Handle is
Comfortable - Age Range 77+

161

The Two Buttons are at an Adequate Distance Apart per Age Range
Of the test subjects within age range 21 — 45, 4% of normal males and 7% of

normal females, 100% of secondary males, and 25% secondary females strongly agreed
that the two buttons are at an adequate distance apart. Of the test subjects within age
range 21 — 45, 70% of normal males, 43% of normal females, and 25% of secondary
females agreed that the two buttons are at an adequate distance apart. Of the test
subjects within age range 21 — 45, 9% of normal males neither agreed nor disagreed that
the two buttons are at an adequate distance apart. Of the test subjects within age range
21 — 45, 17% of normal males, 43% of normal females, and 25% of secondary females
disagreed that the two buttons are at an adequate distance apart. Of the test subjects
within age range 21 — 45, 7% of normal females and 25% of secondary females strongly

disagreed that the two buttons are at an adequate distance apart. (Figure 128)

 

Normal and Secondary Test Subject:
The Distance of the Two Buttons are at an Adequate
Distance Apart - Age Range 21 - 45

   
 
  
 
  
 
 

Nomai Male

l I Nomi Femle

Test Subject, %
LII
O

1 D Secondary Male
1 D Secondary Fermle

 

0 ... .. a
Strongly Agree Neither Disagree Strongly
Agree Agree Disagree

nor
Disagree
Test Subject Response

 

 

 

Figure 128 — Normal and Secondary Test Subject: The Distance of the Two Buttons is
Adequate - Age Range 21 — 45

162

Of the test subjects within age range 46 — 60, 50% of normal males, 25% of
normal females, 20% of secondary males, and 40% secondary females strongly agreed
that the two buttons are at an adequate distance apart. Of the test subjects within age
range 46 — 60, 50% of normal males, 75% of normal females, 40% of secondary
females, and 7% of secondary females agreed that the two buttons are at an adequate
distance apart. Of the test subjects within age range 46 — 60, 7% of secondary females
neither agreed nor disagreed that the two buttons are at an adequate distance apart. Of
the test subjects within age range 46 — 60, 20% of secondary males, and 7% of
secondary females disagreed that the two buttons are at an adequate distance apart. Of
the test subjects within age range 46 — 60, 20% of secondary males and 40% of
secondary females strongly disagreed that the two buttons are at an adequate distance

apart. (Figure 129)

 

Normal and Secondary Test Subject:
The Distance of the Two Buttons are at an Adequate
Distance Apart - Age Range 46 - 60

  
  

j Norrrral Male -

j I Nomnl Fermle

lg ‘ El Secondary Male

Test Subject, %
8

 

a Cl Secondary Female;
5

0 .
Strongly Agree Neither Disagree Strongly
Agree Agree Disagree
nor
Disagree
Test Subject Response

 

 

 

Figure 129 - Normal and Secondary Test Subject: The Distance of the Two Buttons is
Adequate - Age Range 46 — 60

163

Of the test subjects within age range 60 — 77, 9% of secondary females strongly
agreed that the two buttons are at an adequate distance apart. Of the test subjects within
age range 60 — 77, 33% of normal males, 25% of normal females, and 27% of
secondary females agreed that the two buttons are at an adequate distance apart. Of the
test subjects within age range 60 — 77, 100% of normal males, 33% of normal females,
50% secondary males, and 9% secondary females neither agreed nor disagreed that the
two buttons are at an adequate distance apart. Of the test subjects within age range
60 — 77, 33% of normal females, and 27% of secondary females disagreed that the two
buttons are at an adequate distance apart. Of the test subjects within age range 60 — 77,
27% of secondary females strongly disagreed that the two buttons are at an adequate

distance apart. (Figure 130)

 

Normal and Secondary Test Subject:
The Distance of the 'IVvo Buttons are at an Adequate
Distance Apart - Age Range 60 - 77

  
 
 
  

 

 

 

=\° W
:9: 60 Nomi Male
'E 50 I Nor-rm] Female
to 40
a 30 [3 Secondary Male
[- 3 . l C] Secondary Fermle
0 a.
Strongly Agree Neither Disagree Strongly
Agree Agree Disagree
nor
Disagree

 

 

Test Subject Response

Figure 130 — Normal and Secondary Test Subject: The Distance of the Two Buttons is
Adequate - Age Range 60 — 77

164

Of the test subjects within age range 77+, 50% of secondary males and 14%
secondary females strongly agreed that the two buttons are at an adequate distance
apart. Of the test subjects within age range 77+, 50% of normal males, 100% of normal
females, 50% of secondary males, and 29% of secondary females agreed that the two
buttons are at an adequate distance apart. Of the test subjects within age range 77+, 14%
of secondary females neither agreed nor disagreed that the two buttons are at an
adequate distance apart. Of the test subjects within age range 77+, 50% of normal males
and 43% of secondary females disagreed that the two buttons are at an adequate

distance apart. (Figure 131)

 

Normal and Secondary Test Subject:
The Distance of the Two Buttons are at an Adequate
D'wtance Apart - Age Range 77+

   
  
  
 
 

 

I Norrnai Male
I Norrnai Fermie
1] Secondary Male

Test Subject, %

 

 

CI Secondary Fennie

 

Strongly Agree Neither Disagree Strongly
Agree Agree Disagree
nor
Disagree

Test Subject Reponse

 

;

 

4

Figure 131 — Normal and Secondary Test Subject: The Distance of the Two Buttons is
Adequate - Age Range 77+

165

The Distance of the Buttons are at Comfortable Distance Apart for Individuals with
Decreased Physical Hand Dexterity, Such as Gripping or Pinching Strength, per Age
Range Of the test subjects within age range 21 — 45, 7% of normal females and 100%
of secondary males strongly agreed that the distance of the buttons are at a comfortable
distance apart for individuals with decreased physical hand dexterity, such as gripping
or pinching strength. Of the test subjects within age range 21 — 45 , 39% of normal
males and 36% of normal females agreed that the two buttons are at an adequate
distance apart. Of the test subjects within age range 21 — 45, 26% of normal males, 21%
of normal females, and 25% secondary females neither agreed nor disagreed that the
distance of the buttons are at a comfortable distance apart for individuals with decreased
physical hand dexterity, such as gripping or pinching strength. Of the test subjects
within age range 21 - 45, 35% of normal males, 29% of normal females and 50% of
secondary females disagreed that the distance of the buttons are at a comfortable
distance apart for individuals with decreased physical hand dexterity, such as gripping
or pinching strength. Of the test subjects within age range 21 — 45, 7% of normal
females and 25% of secondary females, strongly disagreed that the distance of the

buttons are at a comfortable distance apart for individuals with decreased physical hand

dexterity, such as gripping or pinching strength. (Figure 132)

166

 

Normal and Secondary Test Subject:

The Distance of the Buttons is Comfortable for
Individuals with Decreased Physical Hand Dexterity,
Such as Gripping or Pinching Strength -

Age Range 21 - 45

 
   
  
 

‘ I Nonml Male

l
l I Name] Fennle

.l

' El Secondary Male
El Secondary Female

Test Subject, %
LII
O

 

10 "
0 ,
Strongly Agree Neither Disagree Strongly
Agree Agree Disagree
nor
Disagree
Test Subject Response

 

 

Figure 132 — Normal and Secondary Test Subject: The Distance of the Buttons is
Comfortable for Individuals with Decreased Physical Hand Dexterity, Such as Gripping
and Pinching Strength - Age Range 21 — 45

167

Of the test subjects within age range 46 — 60, 25% of normal females, 20% of
secondary males, and 27% secondary females strongly agreed that the distance of the
buttons are at a comfortable distance apart for individuals with decreased physical hand
dexterity, such as gripping or pinching strength. Of the test subjects within age range
46 — 60, 100% of normal males, 50% of normal females, 40% of secondary males, and
47% of secondary females agreed that the distance of the buttons are at a comfortable
distance apart for individuals with decreased physical hand dexterity, such as gripping
or pinching strength. Of the test subjects within age range 46 — 60, 25% of normal
females and 20% secondary females neither agreed nor disagreed that the distance of
the buttons are at a comfortable distance apart for individuals with decreased physical
hand dexterity, such as gripping or pinching strength. Of the test subjects within age
range 46 — 60, 7% of secondary females disagreed that the distance of the buttons are at
a comfortable distance apart for individuals with decreased physical hand dexterity,
such as gripping or pinching strength. Of the test subjects within age range 46 — 60,
40% of secondary males and 40% of secondary females strongly disagreed that the
distance of the buttons are at a comfortable distance apart for individuals with decreased

physical hand dexterity, such as gripping or pinching strength. (Figure 133)

168

 

Normal and Secondary Test Subject:

The Distance of the Buttons is Comfortable for
Individuals with Decreases Physical Hand Dexterity,
Such as Gripping or Pinching Strength -

Age Range 46 - 60

 

‘ I Noml Male
I Nonml Fennle

El Secondary Male

Test Subject, °/o

 

 

El Secondary Fennle

 

 

Strongly Agree Neither Disagree Strongly
Agree Agree Disagree
nor
Disagree

Test Subject Response

 

 

 

Figure 133 — Normal and Secondary Test Subject: The Distance of the Buttons is
Comfortable for Individuals with Decreased Physical Hand Dexterity, Such as Gripping
and Pinching Strength - Age Range 46 — 60

169

Of the test subjects within age range 60 — 77, 33% of normal females and 27%
of secondary females agreed that the two buttons are at an adequate distance apart. Of
the test subjects within age range 60 -— 77, 100% of normal males, 33% normal females,
75% secondary males, and 9% secondary females neither agreed nor disagreed that the
distance of the buttons are at a comfortable distance apart for individuals with decreased
physical hand dexterity, such as gripping or pinching strength. Of the test subjects
within age range 60 — 77, 33% of normal females, 25% of secondary male and 45% of
secondary females disagreed that the distance of the buttons are at a comfortable
distance apart for individuals with decreased physical hand dexterity, such as gripping
or pinching strength. Of the test subjects within age range 60 — 77, 18% of secondary
females strongly disagreed that the distance of the buttons are at a comfortable distance
apart for individuals with decreased physical hand dexterity, such as gripping or

pinching strength. (Figure 134)

170

 

Normal and Secondary Test Subject:

The Distance of the Buttons is Comfortable for
Individuals with Decreases Physical Hand Dexterity,
Such as Gripping or Pinching Strength -

Age Range 60 - 77

    
 
 
  

I I Normal Male —
l I Nomral Female

‘ Cl Secondary Male

Test Subject, %
LII
O

 

10 in Secondary Female
0 , " 3‘
Strongly Agree Neither Disagree Strongly
Agree Agree Disagree
nor
Disagree
Test Subject Response

 

 

 

Figure 134 — Normal and Secondary Test Subject: The Distance of the Buttons is
Comfortable for Individuals with Decreased Physical Hand Dexterity, Such as Gripping
and Pinching Strength - Age Range 60 — 77

171

Of the test subjects within age range 77+, 14% of secondary females strongly
agreed that the distance of the buttons are at a comfortable distance apart for individuals
with decreased physical hand dexterity, such as gripping or pinching strength. Of the
test subjects within age range 77+, 50% of normal males, 100% of normal females, 50%
of secondary males, and 14% of secondary females agreed that the two buttons are at an
adequate distance apart. Of the test subjects within age range 77+, 50% of normal males
and 29% of secondary females neither agreed nor disagreed that the distance of the
buttons are at a comfortable distance apart for individuals with decreased physical hand
dexterity, such as gripping or pinching strength. Of the test subjects within age range
77+, 50% of secondary males and 29% of secondary females disagreed that the distance
of the buttons are at a comfortable distance apart for individuals with decreased
physical hand dexterity, such as gripping or pinching strength. Of the test subjects
within age range 77+, 14% of secondary females strongly disagreed that the distance of
the buttons are at a comfortable distance apart for individuals with decreased physical

hand dexterity, such as gripping or pinching strength. (Figure 135)

172

 

Normal and Secondary Test Subject:

The Distance of the Buttons is Comfortable for
Individuals with Decreases Physical Hand Dexterity,
Such as Gripping or Pinching Strength -

Age Range 77+

    
 
 

E! Nomral Male
60

l I Norrml Female

Test Subject, %
M
o

 

 

30 El Secondary Male
20 El Secondary Fermle
10 ‘ i~——
0 . .
Strongly Agree Neither Disagree Strongly
Agree Agree Disagree
nor
Disagree
Test Subject Response

 

 

Figure 135 — Normal and Secondary Test Subject: The Distance of the Buttons is
Comfortable for Individuals with Decreased Physical Hand Dexterity,
Such as Gripping and Pinching Strength - Age Range 77+

173

I Would Feel Comfort in Knowing that the Medication/Vitamin Supplement
Organizer/Dispenser I Use is Child-Resistant

Of the test subjects within age range 21 — 45, 61% of normal males, 100% of
normal females, 57% of secondary males, 100% of secondary males, and 25% of
secondary females strongly agreed that they would feel comfort in knowing that the
medication/vitamin supplement organizer/dispenser they use is child-resistant. Of the
test subjects within age range 21 — 45, 26% of normal males and 36% of normal
females agreed that they would feel comfort in knowing that the medication/vitamin
supplement organizer/dispenser they use is child-resistant. Of the test subjects within
age range 21 —- 45, 9% of normal males and 50% of secondary females neither agreed
nor disagreed that they would feel comfort in knowing that the medication/vitamin
supplement organizer/dispenser they use is child-resistant. Of the test subjects within
age range 21 — 45, 4% of normal males and 7% of normal females disagreed that they
would feel comfort in knowing that the medication/vitamin supplement
organizer/dispenser they use is child-resistant. Of the test subjects within age range
21 — 45, 25% of secondary females strongly disagreed that they would feel comfort in
knowing that the medication/vitamin supplement organizer/dispenser they use is child-

resistant. (Figure 136)

174

 

Normal and Secondary Test Subject:
I Would Feel Comfort in Knowing that the Dispenser I
Use is Child-Resistant - Age Range 21 - 45

  

 

\°
° F—‘fi
:5: | I Normal Male
E 1 I Norrml Fermle
g 30 I 1:] Secondary Male
0
i" 1:8 IE it! Secondary Fermle
0 h ’———
Strongly Agree Neither Disagree Strongly
Agree Agree Disagree
nor
Disagree
Test Subject Response

 

 

 

Figure 136 — Normal and Secondary Test Subject: I Would Feel Comfort in Knowing
that the Dispenser I Use is Child-Resistant - Age Range 21 — 45

175

Of the test subjects within age range 46 — 60, 50% of normal males, 75% of
normal females, 40% of secondary males, and 53% secondary females strongly agreed
that they would feel comfort in knowing that the medication/vitamin supplement
organizer/dispenser they use is child-resistant. Of the test subjects within age range
46 — 60, 20% of secondary males and 20% of secondary females agreed that they would
feel comfort in knowing that the medication/vitamin supplement organizer/dispenser
they use is child-resistant. Of the test subjects within age range 46 — 60, 50% of normal
males, 25% of normal females, and 13% of secondary females neither agreed nor
disagreed that they would feel comfort in knowing that the medication/vitamin
supplement organizer/dispenser they use is child-resistant. Of the test subjects within
age range 46 — 60, 20% of secondary males and 7% of secondary females disagreed that
they would feel comfort in knowing that the medication/vitamin supplement
organizer/dispenser they use is child-resistant. Of the test subjects within age range
46 — 60, 20% of secondary males and 7% of secondary females strongly disagreed that
they would feel comfort in knowing that the medication/vitamin supplement

organizer/dispenser they use is child-resistant. (Figure 137)

176

 

Normal and Secondary Test Subject:
I Would Feel Comfort in Knowing that the Dispenser I
Use is Child-Resistant - Age Range 46 - 60

‘3‘

 
   
  
    

l I Nome] Male

1 I Nonml Fermle

Test Subject, %
Ur
o

D Secondary Male

 

10 13 Secondary FermIe
0
Strongly Agree Neither Disagree Strongly
Agree Agree Disagree
nor
Disagree
Test Subject Response

 

 

 

Figure 137 — Normal and Secondary Test Subject: I Would Feel Comfort in Knowing
that the Dispenser I Use is Child-Resistant - Age Range 46 — 60

177

Of the test subjects within age range 60 — 77, 25% of secondary males and 18%
secondary females strongly agreed that they would feel comfort in knowing that the
medication/vitamin supplement organizer/dispenser they use is child-resistant. Of the
test subjects within age range 60 — 77, 100% of normal males, 33% of normal females,
25% of secondary males, and 27% of secondary females agreed that they would feel
comfort in knowing that the medication/vitamin supplement organizer/dispenser they
use is child-resistant. Of the test subjects within age range 60 — 77, 67% of normal
females, 50% of secondary males, and 27% secondary females neither agreed nor
disagreed that they would feel comfort in knowing that the medication/vitamin
supplement organizer/dispenser they use is child-resistant. Of the test subjects within
age range 60 — 77, 18% of secondary females disagreed that they would feel comfort in
knowing that the medication/vitamin supplement organizer/dispenser they use is child-
resistant. Of the test subjects within age range 60 — 77, 9% of secondary females
strongly disagreed that they would feel comfort in knowing that the medication/vitamin

supplement organizer/dispenser they use is child-resistant. (Figure 138)

178

 

Normal and Secondary Test Subject:
I Would Feel Comfort in Knowing that the Dispenser I
Use is Child-Resistant - Age Range 60 - 77

' l

E! Secondary Male
I 1]: Secondary Fermle

>° [_._____—
3;“ l I Nomal Male
0 .
7g" ‘ l I Normal Female
(I:
§
l-t

 

 

Strongly
Agree Agree Disagree
nor
D'sagree
Test Subject Response

 

 

 

Figure 138 — Normal and Secondary Test Subject: I Would Feel Comfort in Knowing
that the Dispenser I Use is Child-Resistant - Age Range 60 — 77

179

Of the test subjects within age range 77+, 100% of normal females and 14% of
secondary females strongly agreed that they would feel comfort in knong that the
medication/vitamin supplement organizer/dispenser they use is child-resistant. Of the
test subjects within age range 77+, 50% of normal males and 29% of secondary females
agreed that they would feel comfort in knowing that the medication/vitamin supplement
organizer/dispenser they use is child-resistant. Of the test subjects within age range 77+,
50% of normal males, 50% secondary males, and 43% secondary females neither
agreed nor disagreed that they would feel comfort in knowing that the
medication/vitamin supplement organizer/dispenser they use is child-resistant. Of the
test subjects within age range 77+, 50% secondary males and 14% of secondary females
disagreed that they would feel comfort in knowing that the medication/vitamin

supplement organizer/dispenser they use is child-resistant. (Figure 139)

 

V
Normal and Secondary Test Subject:
I Would Feel Comfort in Knowing that the Dispenser I
Use is Child-Resistant - Age Range 77+

     
   

I Name] Male

I Nonml Female

  
  
 

El Secondary Male

Test Subject, %
“c."

E] Secondary Female

10
0 _. , I
Strongly Agree Neither Disagree Strongly
Agree Agree Disagree
nor
Disagree
Test Subject Response

 

 

 

 

Figure 139 - Normal and Secondary Test Subject: I Would Feel Comfort in Knowing
that the Dispenser I Use is Child-Resistant - Age Range 77+

180

This Package Will Aid in Medication Compliance for Both Individuals with or without
Physical Hand Dexterity ‘

Of the test subjects within age range 21 — 45, 22% of normal males, 43% of
normal females, 100% of secondary males, and 75% secondary females strongly agreed
that the package will aid in medication compliance for both individuals with or without
physical hand dexterity. Of the test subjects within age range 21 — 45, 57% of normal
males and 43% of normal females agreed that the package will aid in medication
compliance for both individuals with or without physical hand dexterity. Of the test
subjects within age range 21 — 45, 17% of normal males, 14% normal females, and 25%
secondary females neither agreed nor disagreed that the package will aid in medication
compliance for both individuals with or without physical hand dexterity. Of the test
subjects within age range 21 — 45, 4% of normal males disagreed that the package will

aid in medication compliance for both individuals with or without physical hand

dexterity. (Figure 140)

181

 

 

Normal and Secondary Test Subject:
This Package Will Aid in Medication Compliance for Both
Individuals with or without Physical Hand Dexterity -
Age Range 21 - 4

    

I Norrml Male

I Nonml Female

D Secondary Male
D Secondary Female

Test Subject, %
u.
G

 

 

Strongly Agree Neither Disagree Strongly
Agree Agree nor Disagree
Disagree

Test Subject Response

 

 

 

Figure 140 — Normal and Secondary Test Subject: This Package will Aid in Medication
Compliance for Both Individuals with or Without Decreased Physical Hand Dexterity -
Age Range 21 — 45

182

Of the test subjects within age range 46 — 60, 4% of normal males, 7% of normal
females, 100% of secondary males, and 25% secondary females strongly agreed that the
package will aid in medication compliance for both individuals with or without physical
hand dexterity. Of the test subjects within age range 46 — 60, 50% of normal males,
50% of normal females, 20% of secondary males, and 27% of secondary females agreed
that the package will aid in medication compliance for both individuals with or without
physical hand dexterity. Of the test subjects within age range 46 - 60, 7% of secondary
females neither agreed nor disagreed that the package will aid in medication compliance
for both individuals with or without physical hand dexterity. Of the test subjects within
age range 46 — 60, 20% of secondary males and 7% of secondary females disagreed that
the package will aid in medication compliance for both individuals with or without
physical hand dexterity. Of the test subjects within age range 46 — 60, 20% of secondary
males and 27% of secondary females strongly disagreed that the package will aid in

medication compliance for both individuals with or without physical hand dexterity.

(Figure 141)

183

 

 

Normal and Secondary Test Subject:
This Package erl Aid in Medication Compliance for Both
Individuals with or without Physical Hand Dexterity -
Age Range 46 - 60

    

8

70'

 

8

I Nonml Male

50 I Nomral Fermle

8

30 . 1;, 4, El Secondary Male

Test Subject, %

8

 

 

10 _ Cl Secondary Fermle

 

O

Strongly Agree Neither Disagree Strongly
Agree Agree nor Disagree
Disagree

Test Subject Response

 

 

 

Figure 141 — Normal and Secondary Test Subject: This Package will Aid in Medication
Compliance for Both Individuals with or Without Decreased Physical Hand
Dexterity - Age Range 46 — 60

184

Of the test subjects within age range 60 — 77, 18% secondary females strongly
agreed that the package will aid in medication compliance for both individuals with or
without physical hand dexterity. Of the test subjects within age range 60 — 77, 67% of
normal females, 75% of secondary males, and 64% of secondary females agreed that
the package will aid in medication compliance for both individuals with or without
physical hand dexterity. Of the test subjects within age range 60 — 77, 100% of normal
males, 33% normal females, 25% of secondary males, and 9% secondary females
neither agreed nor disagreed that the package will aid in medication compliance for
both individuals with or without physical hand dexterity. Of the test subjects within age
range 60 — 77, 9% of secondary females disagreed that the package will aid in
medication compliance for both individuals with or without physical hand dexterity.

(Figure 142)

 

Normal and Secondary Test Subject:
This Package WI“ Aid in Medication Compliance for Both
Individuals with or without Physical Hand Dexterity -
Age Range 60 - 77

  

 

\°
9 i f‘_ —
:3, 60 Nor-rml Male
'3 50 I Nonml Fermle
m
E 33 C] Secondary Male
l‘ 20 0 Secondary Fermle
10 fl
0 "
Strongly Agree Neither Disagree Strongly
Agree Agree nor Disagree
Disagree
Test Subject Response

 

 

P

Figure 142 — Normal and Secondary Test Subject: This Package will Aid in Medication
Compliance for Both Individuals with or Without Decreased Physical Hand
Dexterity - Age Range 60 —- 77

 

185

Of the test subjects within age range 77+, 100% of normal females, 50% of
secondary males, and 14% of secondary females strongly agreed that the package will
aid in medication compliance for both individuals with or without physical hand
dexterity. Of the test subjects within age range 77+, 100% of normal males and 29% of
secondary females agreed that the package will aid in medication compliance for both
individuals with or without physical hand dexterity. Of the test subjects within age
range 77+, 50% of secondary males and 43% secondary females neither agreed nor
disagreed that the package will aid in medication compliance for both individuals with
or without physical hand dexterity. Of the test subjects within age range 77+, 14%
secondary females disagreed that the package will aid in medication compliance for

both individuals with or without physical hand dexterity. (Figure 143)

 

Normal and Secondary Test Subject:
This Package Will Aid in Medication Compliance for Both
Individuals with or without Physical Hand Dexterity -
Age Range 77+

 
 
 
  

Nonnal Male
I Nome] FermIe

El Secondary Male

Test Subject, %
8

El Secondary Ferrele

10 ,
0 ‘ p ,
Strongly Agree Neither Disagree Strongly
Agree Agree nor Disagree
Disagree
Test Subject Response

 

 

 

Figure 143 — Normal and Secondary Test Subject: This Package will Aid in Medication
Compliance for Both Individuals with or Without Decreased Physical Hand
Dexterity - Age Range 77+

186

If Manufactured, I have a Desire to Own and Use this Package
Of the test subjects within age range 21 — 45, 22% of normal males, 7% of

normal females, 100% of secondary males, and 25% secondary females strongly agreed
that, if manufactured, they have a desire to own and use the newly designed package. Of
the test subjects within age range 21 — 45, 43% of normal males, 57% of normal
females, and 50% of secondary females agreed that, if manufactured, they have a desire
to own and use the newly designed package. Of the test subjects within age range

21 — 45, 26% of normal males, 21% normal females, and 25% of secondary females
neither agreed nor disagreed that, if manufactured, they have a desire to own and use

the newly designed package. Of the test subjects within age range 21 — 45, 9% of
normal males and 14% of normal females disagreed that, if manufactured, they have a

desire to own and use the newly designed package. (Figure 144)

 

Normal and Secondary Test Subject:
If Manufactured, I Have a Desire to Own and Use this
Package - Age Range 21 - 45

   
 
  

   
  

Nome] Male

   

‘
l I Nome] Female

Test Subject, %
‘6

 

40 ,
30 l E! Secondary Male
%8 g i D Secondary Fermle

Strongly Agree Neither Disagree Strongly

Agree Agree Disagree
nor
Disagree
Test Subject Response

 

 

 

Figure 144 — Normal and Secondary Test Subject: If Manufactured, I Have a Desire to
Own and Use This Package - Age Range 21 — 45

187

Of the test subjects within age range 46 — 60, 50% of normal males, 50% of
normal females, 40% of secondary males, and 40% secondary females strongly agreed
that, if manufactured, they have a desire to own and use the newly designed package. Of
the test subjects within age range 46 — 60, 50% of normal males, 50% of normal
females, 20% of secondary males, and 20% of secondary females agreed that, if
manufactured, they have a desire to own and use the newly designed package. Of the
test subjects within age range 46 — 60, 20% of secondary males neither agreed nor
disagreed that, if manufactured, they have a desire to own and use the newly designed
package. Of the test subjects within age range 46 — 60, 20% of secondary males and 7%
of secondary females disagreed that, if manufactured, they have a desire to own and use
the newly designed package. Of the test subjects within age range 46 — 60, 33% of
secondary females strongly disagreed that, if manufactured, they have a desire to own

and use the newly designed package. (Figure 145)

 

Normal and Secondary Test Subject:
If Manufactured, I Have a Desire to Own and Use this
Package - Age Range 46 - 60

 
  

; ENonml Male
‘ I Nom'al Fermle

   
 

Test Subject, %
8

 

30 ' D Secondary Male
l
f?) D Sciondary Female
0
Strongly Agree Neither Disagree Strongly
Agree Agree Disagree
nor
Disagree
Test Subject Response

 

 

Figure 145 — Normal and Secondary Test Subject: If Manufactured, I Have a Desire to
Own and Use This Package - Age Range 46 — 60

188

Of the test subjects within age range 60 — 77, 25% of secondary males strongly
agreed that, if manufactured, they have a desire to own and use the newly designed
package. Of the test subjects within age range 60 — 77, 25% secondary males and 36%
secondary females agreed that, if manufactured, they have a desire to own and use the
newly designed package. Of the test subjects within age range 60 — 77, 100% of normal,
67% of normal females, 25% of secondary males, and 27% of secondary females
neither agreed nor disagreed that, if manufactured, they have a desire to own and use
the newly designed package. Of the test subjects within age range 60 — 77, 33% of
normal females, 25% secondary males, and 18% of secondary females disagreed that, if
manufactured, they have a desire to own and use the newly designed package. Of the
test subjects within age range 60 — 77, 18% of secondary females strongly disagreed

that, if manufactured, they have a desire to own and use the newly designed package.

 

(Figure 146)
Normal and Secondary Test Subject:
If Manufactured, I Have a Desire to Own and Use this
Package - Age Range 60 - 77
100
90

  
 
 
 
  

‘ I Nomel Male
l I Nom'al Fermle

1 El Secondary Male

Test Subject, %
M
o

%8 V V as: m g {DSecondary Female
0 . . ———
Strongly Agree Neither Disagree Strongly
Agree Agree Disagree
nor
Disagree
Test Subject Response

 

 

 

Figure 146 — Normal and Secondary Test Subject: If Manufactured, I Have a Desire to
Own and Use This Package - Age Range 60 - 77

189

Of the test subjects within age range 77+, 100% of normal females and 14% of
secondary females strongly agreed that, if manufactured, they have a desire to own and
use the newly designed package. Of the test subjects within age range 77+, 50% of
secondary males and 14% of secondary females agreed that, if manufactured, they have
a desire to own and use the newly designed package. Of the test subjects within age
range 77+, 29% of secondary females neither agreed nor disagreed that, if
manufactured, they have a desire to own and use the newly designed package. Of the
test subjects within age range 77+, 100% of normal males, 50% of secondary males,
and 43% of secondary females disagreed that, if manufactured, they have a desire to

own and use the newly designed package. (Figure 147)

 

Normal and Secondary Test Subject:
If Manufactured, I Have a Desire to Own and Use this
Package - Age Range 77+

l E! Noml Male
l

. I Norrml FermIe
l
H] Secondary Male

Test Subject, %

 

‘ IE] Secondary FerrraleJi ‘

 

Strongly Agree Neither Disagree Strongly
Agree Agree Disagree
nor
Disagree

Test Subject Res ponse

 

 

 

Figure 147 — Normal and Secondary Test Subject: If Manufactured, I Have a Desire to
Own and Use This Package - Age Range 77+

190

 

Bibliography

 

 

 

191

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