title: Exploring consumer opinions on the presentation of side-effects information in Australian Consumer Medicine Information leaflets.
abstract: Consumer 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.
  
  
  
  To 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.
  
  
  
  Fuzzy 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.
  
  
  
  Three 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.
  
  
  
  All 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.
  
  
  
  One 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.
authors.affiliation: Faculty of Pharmacy, The University of Sydney, Sydney, NSW, Australia.
authors.forename: Vivien
authors.initials: V
authors.lastname: Tong
authors.affiliation: School of Healthcare, University of Leeds, Leeds, UK.
authors.forename: David K
authors.initials: DK
authors.lastname: Raynor
authors.affiliation: Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
authors.forename: Susan J
authors.initials: SJ
authors.lastname: Blalock
authors.affiliation: Faculty of Pharmacy, The University of Sydney, Sydney, NSW, Australia.
authors.forename: Parisa
authors.initials: P
authors.lastname: Aslani
mesh_terms: D000368:Aged; D000959:Antihypertensive Agents; D001290:Attitude; D000077144:Clopidogrel; D003071:Cognition; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D017144:Focus Groups; D057220:Health Literacy; D000066506:Heuristics; D006801:Humans; D008297:Male; D008875:Middle Aged; D009517:New South Wales; D010174:Pamphlets; D010975:Platelet Aggregation Inhibitors; D055553:Prescription Drugs; D017257:Ramipril; D009626:Terminology as Topic; D013988:Ticlopidine / Q000031:analogs & derivatives
chemical_list: D000959:Antihypertensive Agents; D010975:Platelet Aggregation Inhibitors; D055553:Prescription Drugs; D000077144:Clopidogrel; D017257:Ramipril; D013988:Ticlopidine
keywords: consumer opinions; risk communication; side effects; written medicine information