Abstract
BackgroundConsumer Medicine Information (CMI) is a brand‐specific and standardized source of written medicine information available in Australia for all prescription medicines. Side‐effect information is poorly presented in CMI and may not adequately address consumer information needs.ObjectiveTo explore consumer opinions on (i) the presentation of side‐effect information in existing Australian CMI leaflets and alternative study‐designed CMIs and (ii) side‐effect risk information and its impact on treatment decision making.DesignFuzzy trace, affect heuristic, frequency hypothesis and cognitive‐experiential theories were applied when revising existing CMI side‐effects sections. Together with good information design, functional linguistics and medicine information expertise, alternative ramipril and clopidogrel CMI versions were proposed. Focus groups were then conducted to address the study objectives.Participants and settingThree focus groups (n = 18) were conducted in Sydney, Australia. Mean consumer age was 58 years (range 50–65 years), with equal number of males and females.ResultsAll consumers preferred the alternative CMIs developed as part of the study, with unequivocal preference for the side‐effects presented in a simple tabular format, as it allowed quick and easy access to information. Consumer misunderstandings reflected literacy and numeracy issues inherent in consumer risk appraisal. Many preferred no numerical information and a large proportion preferred natural frequencies.ConclusionsOne single method of risk presentation in CMI is unable to cater for all consumers. Consumer misunderstandings are indicative of possible health literacy and numeracy factors that influence consumer risk appraisal, which should be explored further.
Highlights
Medicine information helps increase consumer understanding, address consumers’ information needs and assist in informed decision making.[1,2] Consumers have considered written medicine information (WMI) as an important and reliable source of medicine information.[3]
All consumers preferred the alternative Consumer Medicine Information (CMI) developed as part of the study, with unequivocal preference for the sideeffects presented in a simple tabular format, as it allowed quick and easy access to information
One single method of risk presentation in CMI is unable to cater for all consumers
Summary
Consumers seek side-effects information, alongside other information critical for safe medicines use.[5,6,7] There is a need for detailed, comprehensive side-effects and medicine safety information to be made available for consumers at a level that they can understand.[8,9] side-effects and the likelihood of experiencing a side-effect is highly coveted by consumers,[10,11] where the need for their inclusion in WMI is recognized.[12] Previous work has noted that consumers prefer sideeffects to be categorized according to likelihood and severity[12], where some have felt that sideeffects information presented in its entirety will help facilitate informed treatment decision making.[8].
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