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Consumer opinions on adverse events associated with medicines and vaccines

机译：消费者对与药品和疫苗相关的不良事件的看法

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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.
机译：简介：尽管澳大利亚消费者不良事件（AE）报告系统已有50多年的历史了，但报告率仍然很低。需要进一步了解消费者对AE的看法和经验，以进一步确定影响他们参与AE报告的因素。目的：本研究的目的是探讨消费者对可能与药物和疫苗有关的不良事件的观点，以及他们对处理和报告不良事件的经验和理解。方法：在整个悉尼大都会进行了六个焦点小组讨论，共有48位成年人参加。制定了半结构化焦点小组主题指南，以探讨消费者对AE的理解，经验和采取的措施;以及管理治疗的利弊的观点。讨论在参加者允许的情况下进行录音，并逐字记录。成绩单进行了主题分析。结果：消费者承认有潜在的副作用（SEs），但是对口头描述（例如“ common”）的SE风险估计不准确。消费者对治疗的利弊的评估受到诸如医疗状况，以前的经历和信念等因素的影响。尽管许多企业都有过SE，但消费者仅在认为严重或有麻烦时才报告。对消费者AE报告系统的了解最少。医生是报告的主要途径。消费者更倾向于选择医生作为向独立机构报告不良事件的中介。结论：显而易见，消费者对AE报告系统缺乏了解。由于利益/危害风险评估，信息搜索和AE报告偏好固有的复杂性，因此需要消费者更好地了解AE和可用于报告的系统。

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