Consumer opinions on adverse events associated with medicines and vaccines
Received 6 March 2018
Accepted for publication 2 May 2018
Published 31 July 2018 Volume 2018:12 Pages 1383—1392
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Amy Norman
Peer reviewer comments 3
Editor who approved publication: Dr Johnny Chen
Parisa Aslani,1 Kim Hamrosi,1 Vivien Tong,1 Timothy F Chen,1 Jane Cook,2 Romano Fois,1 Theresa McGarry,3 Carter Moore,4 Rodney Peters,5 Sarah Spagnardi,6 Karen Whitelock7
1Faculty of Pharmacy, The University of Sydney, Camperdown, NSW, Australia; 2Therapeutic Goods Administration, Canberra, ACT, Australia; 3Celgene Pty Ltd., Southbank, VIC, Australia; 4Consumers Health Forum of Australia, Canberra, ACT, Australia; 5Pharmacovigilant Consultant, Sydney, NSW, Australia; 6NPS MedicineWise, Sydney, NSW, Australia; 7Novartis Pharmaceuticals Australia Pty Ltd., Sydney, NSW, Australia
Introduction: Despite the availability of an Australian consumer adverse event (AE) reporting system for over 50 years, reporting rates remain low. A comprehensive understanding of consumer perceptions and experiences regarding AEs is needed to further ascertain factors impacting their engagement in AE reporting.
Aim: The aim of this study was to explore consumer opinions about AEs potentially associated with medicines and vaccines, and their experiences and understanding of managing and reporting AEs.
Methods: Six focus groups were conducted across metropolitan Sydney with a total of 48 adult participants. A semi-structured focus group topic guide was developed to explore consumers’ understanding, experiences, and actions taken in relation to AEs; and perspectives on managing treatment benefits and harms. Discussions were audio-recorded with participant permission and transcribed verbatim. Transcripts were thematically analyzed.
Results: Consumers acknowledged the potential for side effects (SEs), however inaccurately estimated SE risk in response to verbal descriptors such as “common.” Consumer appraisal of treatment benefits and harms was influenced by factors such as medical condition(s), previous experiences, and beliefs. Although many had experienced SEs, consumers only reported them if considered severe or troublesome. Minimal awareness of consumer AE reporting systems was evident. Doctors were the primary avenue for reporting; consumers preferred doctors to act as the intermediary in reporting AEs to an independent body.
Conclusion: Consumers’ lack of awareness of AE reporting systems was evident. With the complexities inherent in benefit/harm risk appraisal, information seeking, and AE reporting preferences, better consumer understanding of AEs and the systems available for reporting is needed.
Keywords: patient, reporting, side effects, qualitative, focus groups, drugs, vaccines
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