Examining the conspicuousness and prominence of two required warnings on OTC pain relievers (original) (raw)

The Influence of Need for Cognition and Principal Display Panel Factors on Over-the-Counter Drug Facts Label Comprehension

Health Communication, 2012

Nearly all work aimed at optimizing the ability of labeling to communicate over-the-counter (OTC) drug information has focused on back-of-the-package characteristics, such as the Drug Facts label. The effects of front of the package, or principal display panel (PDP) factors, have largely been neglected by researchers. Similarly, heterogeneity in consumers' approach to new information has received scant attention in the context of OTC drugs. This preliminary study tested the hypothesis that display of a drug's brand name on the PDP and individuals' need for cognition influence comprehension of Drug Facts label information. University students (n = 212) that had experienced heartburn but not used the drug class being studied constituted the primary analysis cohort. Students were randomly assigned to review one of two PDPs (brand name or generic), followed by a Drug Facts label and a series of questions related to selection and usage of the drug. Participants with low need for cognition were influenced by the brand name PDP, as those exposed to a PDP featuring a brand (vs. generic) spent less time reading the Drug Facts label and demonstrated lower comprehension of the label information on proper drug selection. These findings suggest that further research is needed to understand the impact of PDP contents and cognitive characteristics of consumers on the communication of OTC drug information. Health care providers should consider communication strategies that account for the challenges patients face in using OTC drugs properly.

Consumer Attention to an Over-the-counter Warning in Four Different Styles of Design

Packaging Technology and Science, 2012

The study consisted of three objectives: (a) to test the relative prominence and conspicuousness of a warning required by US law to be conspicuous; (b) to explore whether or not the conspicuousness of the said warning can be enhanced graphically; and (c) to develop preliminary data for power analysis that would guide decisions related to sample size in future studies. Seventeen subjects viewed four over-the-counter drug packages (each with a different style of warning)along with five other products while wearing an eye-tracking device. Four styles of warning were used on the over-the-counter drug packages: no outline and no fill, outline and no fill, no outline and fill, and outline and fill. The surface area and the placement of the warnings were held constant across all four designs andwere consistent with those on commercially available products. Collected data were broken into five zones: warning, brand name, strength, product benefit, and net weight. Despite the fact that US law requires it to be conspicuous, the tested warning was significantly less noticeable than the brand name (objective one) for all dependent variables analyzed (a=0.05). No significant difference was indicated for the varied warning designs (objective two). This could be because not much can be done to enhance prominence when constrained to the limited space that is typically used for such warnings or because of the limited sample size. Power calculations suggest that a sample size of nearly200 subjects would be required to detect a 2.5-seconds mean difference at 80% con fidence (objective three).

The Influence of Pictorials on the Comprehension and Recall of Pharmaceutical Safety and Warning Information

International Journal of Cognitive Ergonomics, 1998

Nonverbal symbols such as pictorials are increasingly being recommended and used to convey warnings and other safety-related infonnation. Although fully redundant text and pictorial messages often facilitate performance, it is unknown what may result when textual instructions are accompanied by an incomplete set of pictorials, in which each and every textual item is not supplemented by an accompanying pictorial. To evaluate the practice of communicating information using various pictorial and text formats, fictitious yet realistic-appearing medication instruction sheets were created that presented eight dosing instructions in the following fonnats: Text alone , pictorials alone, fully redundant text and pictorials, text with four instructions accompanied by pictorials (incomple te pictorials) , and no instructions (control). Following exposure to one of the instruction sheets, participants were given a free: recall test on the content of the medication information. Results demonstrated that insuuctions from the fully redundant text and pictorials format were recalled more often than instructions from the other formats. Also, the fully redundant text and pictorials format was given higher ratings than the other formats, whereas the pictorials alone and control fonnats received the lowest ratings. An age-related decline in recall was observed, with older adults recalling far less infonnation than undergraduates or younger adults.

THE INFLUENCE OF PICTORIALS ON EVALUATIONS OF PRESCRIPTION MEDICATION INSTRUCTIONS

Drug Information Journal, 1997

Nonverbal symbols such as pictorials are increasingly being used to convey safety-related infonnation. Pictorials may be useful to persons who cannot read printed verbal messages because of inadequate reading skills or unfamiliarity with the language used in the message. One application for pictorials is in the depiction of safety and warning information on pharmaceutical products. The present study examined consumer preference by evaluating prescription medication instructions which differed in textual and pictorial presentation format. Results indicate that parlicipants preferred a fully redundant (com-bined) text and pictorials fonnat, rating it more effective and easier to understand and remember. The data also show a strong preference for text-only compared to pictorials-only instructions. Furthermore, there was no difference between text-only and partial-pictorial (text with an incomplete set of corresponding pictorials) formats, indicating the belief that a complete absence of pictorials was just as effective as a limited set of pictorials. The results have implications for accompanying textual instructions with an incomplete set of pictorials.

Attention! Read it carefully! On the (in)efficiency of warning labels

2016

ATTENTION! READ IT CAREFULLY! ON THE (IN)EFFICIENCY OF WARNING LABELS CAROLINE DE ARAÚJO PUPO HAGEMEYER UNIVERSIDADE FEDERAL DE SANTA CATARINA 2016 Supervising Professor: Dr. Richard Malcolm Coulthard Warning labels and Patient Information Leaflets (PILs) play an important role in risk prevention. However, there is evidence that if they are inefficient, consumers are forced to make inferences that may well be different from those intended by the author. Unfortunately, misinferences can lead consumers to adopt behavior that results in serious consequences, which could have been avoided by efficient warnings. A recent area in the Law (Tiersma, 2002), product liability, which deals with cases where the consumer suffers any kind of injury, has been attracting the interest of some Forensic Linguists, who have been working as expert witness aiming at evaluating whether the warning labels and PILs inform consumers clearly about either the potential risks or how to use the products safely. ...

ENHANCING THE PERCEIVED READABILITY OF PHARMACEUTICAL CONTAINER LABELS AND WARNINGS: THE USE OF ALTERNATIVE DESIGNS AND PICTORIALS

Proceedings of the Human Factors and Ergonomics Society, 1994

The appropriate use of pharmaceuticals, as well as their hazards, are not commonly known to most people. In fact, the only information available to consumers is usually the material found on the product label. Unfortunately, for some consumers this method of communicating instructions and risks may be ineffective, and potentially dangerous. People may have difficulty with the labels because the print on the label is too small for them to read. Two alternative (tag and fold-out) designs were developed to increase the available surface area for information printed on a fictitious prescription drug label. The alternative label designs were compared to a standard control label. The presence versus the absence of pictorials visually depicting several instructions and warnings was also examined. Participants rated the labels on ease of reading the labels, likelihood of noticing the warnings, likelihood of reading the warnings, preference for each of the labels, and likelihood that they would recommend each label for use by a friend or family member. The results showed that participants (n = 84) preferred the alternative label designs, especially the tag labels, and those with illustrative pictorials. Implications of these results and recommendations for future research in this area are discussed.

Exploring the perspectives of potential consumers and healthcare professionals on the readability of a package insert: a case study of an over-the-counter medicine

European journal of clinical pharmacology, 2014

Purpose To explore and compare the opinions of physicians, pharmacists and potential users on the readability of a package insert of an over-the-counter medicine. Methods Exploratory study based on the administration of a semi-open questionnaire. This instrument was developed according to the readability guideline of the European Medicine Agency (EMA) and used to evaluate participants’ accessibility to, and comprehensibility of, the package insert for diclofenac 12.5 mg tablets. Sixty-three participants were recruited from the Lisbon region and enrolled in three groups: physicians (Dg), pharmacists (Pg) and potential consumers (PCg), with a minimum of 20 participants each. Results Almost all (85 %) of the 20 PCg participants were educated above the 9th grade, although the majority of them (95 %) referred to, at least, one package insert interpretation issue, mainly related to the comprehension of technical terms. Amongst other differences between the groups, the Pg participants (n = 22) obtained a significantly less favourable opinion regarding the layout of the titles. Furthermore, the Pg and Dg (n = 21) participants proposed technical enhancements, such as the use of a table to explain the posology, precautions in case of renal failure, or the recommendation to take the tablets with meals. Conclusions Differences in the way of using the diclofenac tablets are expected, considering the comprehension dissimilarities between health professionals and potential consumers. The package insert of diclofenac 12.5 mg could be enhanced for safer use. Regarding the readability assessment of this package insert, the method proposed in the EMA guidelines might not be as effective as expected. Future research is advisable.

Consumers' Information Processing Objectives and Effects of Product Warnings

Proceedings of the Human Factors Society annual meeting, 1988

Based on human information processing theory it was hypothesized that consumers' information processing objective would influence the amount of time they devoted to examining product labels, their memory for product safety information, and as a result, the likelihood they would comply with safety recommendations. More specifically, it was expected that compared to consumers with an impression-set processing objective, consumers with a memory-set processing objective would: 2) recall more safety-related information; and 3) be more likely to comply with safety recommendations. Results provided unequivocal support for the first two hypotheses and only partial support for the third hypothesis.

Consumers iews on text characteristics of product recall notices

Document Design, 2001

Consumers who have suffered as a result of a product defect can claim compensation from the producer. By placing a product recall notice, producers can reduce their liability. Ideally, such a notice should protect the image of the company as well as warn consumers. The problem is that a clear warning may damage the image of the company that placed the notice. This study reports on experiments carried out among 128 female shoppers to gain insight into how a recall notice should be worded in order to protect the company’s image and, yet to be clear. Split-run tests were carried out to determine whether Minimisation (minimising the danger of the defect) and Bolstering (stressing the company’s good traits) contributed positively to the image of the company and whether inclusion of pictures, a list format, a reader-oriented approach, Minimisation, and Bolstering contrib- uted positively to the clarity of the notice. Likert scales were used to determine which heading drew most attention a...

The effect of alternative product-label design on warning compliance

Many potentially hazardous products are packaged in small containers. Because of the limited amount of space available on these containers for warnings and other information, manufacturers often reduce the size and amount of printed material on the labels. This frequently impairs the message's legibility, noticeability and comprehensibility. Recently, several alternative label designs have been investigated using preference ratings, but whether the designs facilitate safer behaviour has not been determined. In the present experiment, two alternative designs (tag and wings) were compared with a conventional (control) design for their effect on behavioural compliance with a warning on a very small container of glue. Participants performed a parts-assembly task using the glue without being informed of the study's real purpose. Whether participants wore protective gloves as directed by the warning was measured. Results showed that the tag design produced significantly greater compliance than the other two designs. Measures of noticing, reading and recall of the warning mirrored the compliance results. While participants generally preferred the control label, they most preferred the tag warning. Overall, the results suggest that alternative designs like the tag can enhance warning communication and compliance in cases where surface area is limited.