William J. Vigilante

The Preferred Order of Over-the-Counter (Otc) Pharmaceutical Label Components

Recently there has been increasing interest in enabling consumers to more easily acquire information from over-the-counter (OTC) nonprescription pharmaceutical labels. Standardization of label formatting is being considered by industry, government, and health-related professional organizations as a way to facilitate their usability. Standardization can assist consumers in quickly locating information relevant to the safe use of medications. The present research sought to determine whether consumers prefer a certain consistent ordering of OTC drug label component headings. If such consistency is found, the results could serve as a partial basis for a standardized format. Results showed relatively consistent orders across four drugs, three participant groups (adults attending a flea market, older adults, and undergraduates) and four scenarios in which the drugs may be used (scenarios concerning the purchase, consumption, administration to another person, and taking into consideration all possible situations the drug may be used in). A different ordering was found for emergency situations involving the drug. In general, people prefer labels that first provide what the drug is used for (indications), second provide information on associated hazards (warnings, cautions, drug interaction precautions) and use (directions), and third provide information on active ingredients. For emergency situations, however, people prefer having the associated hazards and directions listed first, followed by the indications and active ingredients. The remaining components were ordered (across all scenarios) as follows: safety seal, inactive ingredients, storage instructions, manufacturer information, and the bar code. It is suggested that implementation of label standardization should have sections located to match peoples expectations or schemas.

Hazard Associations of Warning Header Components

There has been relatively little warnings research directed at systematically examining the component features comprising existing warning signs as specified in standards (ANSI Z535) and guidelines (e.g., FMC, 1985; Westinghouse, 1981). This research examines several elemental features found in real-world warning signs to determine their individual as well as their combined effects on peoples hazard perceptions. Various colors, signal words, shapes and configurations—both individually and in combination — comprising existing warning headers as well as newly developed constituents were evaluated in a series of rating and ranking tasks. The results confirmed several existing published recommendations (e.g., the color red is perceived to connote more hazard than other solid colors), but also showed instances where peoples perceptions differed from those assumed in design standards and guidelines. Some newly-developed header configurations (e.g., having a skull icon to the right of the signal world) show promise as alternatives for signaling hazardous conditions.

Applying Usability Engineering Principles to the Design and Testing of Warning Messages

Very little has been published on methods for creating and testing text messages for product warnings. This paper describes how the three main principles of usability engineering (prototyping, empirical user testing, and iterative design) can be applied to the design and evaluation of warning text. Pre-prototype activities that help define the warning requirements are described, followed by a discussion of guidelines for creating and testing design prototypes. Finally, a methodology for formally testing the effectiveness of warning text is presented. The procedure described should be useful to human factors practitioners who are responsible for creating or evaluating textual warnings.

Assessing Risk and Benefit Communication in Direct-to-Consumer Medication Website Advertising

Drug manufacturers have been increasingly marketing their prescription medications using Direct-to-Consumer (DTC) advertisements. This research examines the effects of integrating and separating risks and benefits within prescription drug DTC Website ads and presenting the risk and benefits at different levels of the Website. Two different drug Websites and two different task types (general browsing and item search) were used. Risk and benefit recall, recognition, time-on-task, click rate, and task success for risk and benefit search, as well as risk noticeability, were measured. The risks and benefits were found faster, with fewer clicks, and remembered more often when they were placed higher in the Website and in separate sections. Risks on a fourth level page without a link from the home page were difficult to find. Risks were rated most noticeable when they were presented separately on the home page. Guidelines are provided for the development of DTC Websites.

Direct-to-consumer (DTC) advertising of prescription medications on the World Wide Web : assessing the communication of risks and benefits

Recently, drug manufacturers have been increasingly marketing their prescription medications using Direct-to-Consumer (DTC) advertisements. The current study examines the effects of integrating and separating the risks and benefits within a prescription medication DTC web site advertisement. The study also examined the effects of presenting the risk and benefits at different levels of a web site. Two different drug web sites and two different task types (general browsing and item search) were used. Risk recall, recognition, time-on-task, click rate, and task success were measured. Results from the current study indicated that risk information was found faster, with less clicks, and remembered more often when placed on a second level page linked from the home page. However, the risk information was more difficult to find when it was placed on a fourth level page without a link on the home page. The pattern of effects with the two tasks was similar. No significant differences were found between the two drugs. A set of guidelines is provided for the development of DTC prescription drug web sites based on the results. It is beneficial (a) to present separate risk and benefit information sections and (b) to place risk and benefit information in the top section of the home page or to prominently place a link to the risk information on the home page.

Availability of operator manuals for used consumer products

This research investigates the availability of operator manuals for used (second-hand or resold) consumer products. One hundred people were solicited at a shopping mall and asked various questions about 20 common consumer products (e.g. car, computer, power lawn mower, bicycle, etc.). They were queried about: (a) whether they have ever purchased the products new and/or used and, if purchased used, whether it came with an operator manual or an instruction sheet, (b) whether they personally sold any of the products used, and if so, whether they transferred the operator manual to the receiver, (c) the desirability of having an operator manual; and (d) how much they would be willing to pay for a manual assuming they had to purchase it separately. Participants were also asked to rate each product on familiarity, hazard level, and difficulty of use, and to answer a set of general manual-related questions. A second survey solicited the opinions of 39 professional sellers (dealers) of used products. Findings from both surveys indicate that while operator manuals for some used products are transferred to purchasers at moderate frequencies, others are much lower. In general, participants believed that the inclusion of the operator manual would aid the sale of used products and they were willing to pay extra to have one (particularly for unfamiliar, more hazardous, difficult-to-use products). The results suggest that manufacturers ought to address ways that would make it more likely that consumers retain the operator manual and transfer it to subsequent purchasers at later resale. Additionally, convenient ways of obtaining replacement copies should be provided to ensure that important safety-related information reaches end users.

The Ordering of Over-the-Counter Pharmaceutical Label Components

Recently there has been increasing interest in enabling consumers to more easily acquire information from over-the-counter (OTC) nonprescription pharmaceutical labels. Standardization of the format of labels is being considered by industry, government, and health-related professional organizations as a way to facilitate their usability. Potentially standardization could assist consumers in quickly locating information that they need to use the medication safely. The purpose of the present research is to determine whether consumers have a consistent preference for the ordering of information (component headings) on OTC drug labels. If so then this could serve as a partial basis for standardization. Results showed relatively consistent orders across four drugs and three participant groups (adults attending a flea market, senior citizens, and undergraduates). In general, the data indicate that people prefer that labels first provide what the drug is used for (indications); second provide information on associated hazards (warnings, cautions, drug interaction precautions) and use (directions); and third provide information on active ingredients. The remaining components were preferred in the following order: whether the package is safety sealed, inactive ingredients, storage instructions, manufacturer information, and then finally the bar code. Given the reasonable consistent orders generated by participants it seems plausible that if standardization were implemented that the ordering would roughly reflect this basic ordering.

Direct-to-Consumer (DTC) Prescription Drug Advertising on Television and Online Purchases of Medications

The present research explored several aspects concerning hazard/risk communication in direct-to-consumer (DTC) television advertising. Results indicated that participants frequently encounter DTC ads and some report information seeking as a result. Participants reported that their physicians will fill their requests for DTC advertised drugs. They report infrequently making online (Internet) purchases of prescription drugs possibly due to safety and legal concerns. Implications of the findings for factors/ergonomics (HF/E) professionals are discussed.