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Considering the impact of medicine label design characteristics on patient safety

Originally Published:
2006
Key Point Summary
Key Point Summary Author(s):
Ranjani Varadarajan
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Objectives

The premise of this study is that there is sufficient evidence-based research in areas such as food labeling, chemical labeling, and general warnings that provides systematic evidence on the effects of medication label design characteristics such as font size, color, use of specific language and signal words/warnings on performance behavioral variables such as safety, compliance, understandability, and discriminability.

Methods

The relationship between labels and behavior is complex, requiring understanding of psychological processes, design issues, specific risk domains, standardization and government regulation issues, and, increasingly, legal and litigious affairs. This article is a literature review of all evidence-based studies that have looked at the impact of design characteristics of a medication label on performance behavior variables, and more importantly on patient safety.

Design Implications
Medication label design has an impact on the performance, and thus the safety behavior, of the healthcare staff, as well as patients and their family.
Findings

The authors categorized the label design characteristics into four categories: Signal Words, Color, Label Format and Message Wording.

Signal Words: The authors found that signal words have clear potential for use on medicine labeling and packaging to draw attention to features such as dosage instructions and warning information. This might be particularly useful in home settings, as medical jargon and verbal descriptors of risk are generally poorly understood, yet signal words provide a means of presenting complex hazard information in an understandable form.

Color: Color is the design feature that has been most researched in the medical setting, as an identification aid;  package and dosage identification and discrimination is a critical means of reducing drug confusions. While color has obvious potential to aid the discriminability and categorization of labels and packages, as with signal words, the majority of labeling research that has investigated color has considered its potential as a means of coding the level of hazard implied. In general, research on warning labels, food labels, and general visual displays has been consistent in revealing that the color red is perceived as implying a high level of hazard, followed by colors such as orange and yellow, then blue and green, with white implying the least hazard.

Label Format: The format variables that appear to have most utility are shape, font size, font characteristics and the use of supplemental directives. Shape can be used as a coding aid (perhaps in conjunction with color) and has potential for use in coding the drug dosage strength information. Font characteristics such as TALLman lettering have obvious benefits for increasing the discriminability of text; size is also an important determinant of the readability and noticeability of information and is an important consideration for older users. The shape of a label is a variable that can potentially communicate a level of hazard and be used to increase the “attention-getting” characteristic of the label.

Message Wording: The content of the medication label is very important, and should include the name of the medicine, an expression of strength, the route of administration, dosage, and warnings.

Limitations

As this is a literature review, the contents of this article can become outdated.

Setting
Ambulatory care facilities|Hospitals|Non-healthcare settings|Other healthcare facilities|Residential healthcare facilities
Outcome Category
Error related outcomes|Visibility
Environmental Condition Category
Visibility
Key Point Summary Author(s):
Ranjani Varadarajan
Primary Author
Hellier, E.