关键词: Adverse drug reaction Adverse drug reaction reporting systems Consumer Digital technology Drug safety Pharmacovigilance

来  源:   DOI:10.1007/s00228-024-03729-y

Abstract:
This study aimed to investigate the current knowledge and experiences of consumers in Australia on adverse drug reaction (ADR) reporting and their reasons for reporting or not reporting ADRs, with a focus on the use of digital tools for ADR reporting.
METHODS: A cross-sectional online survey was conducted among adults who had taken medicine in Australia. A structured questionnaire with multiple choice or Likert scale responses with an option for participants to provide free-text responses and pretested for face validity was used. Consumer characteristics, knowledge, and ADR reporting practices were analyzed using descriptive statistics and the chi-square test or Fisher\'s exact test.
RESULTS: A total of 544 survey responses were included in the analysis. The majority of respondents were women (68%), and 22% were aged between 65 and 74 years. Fifty-eight percent (n = 317) of respondents knew that they could report ADRs to either the Therapeutic Goods Administration (TGA), state or territory government health department, or healthcare professionals. Three-quarters (n = 405) of respondents stated that they had experienced an ADR; of these, 36% reported an ADR to either the TGA, state or territory government health department, or healthcare professionals. Among those who reported ADRs, 58% were unaware that they could use digital tools to report ADRs. The main reason for not reporting was that they did not think the ADR was serious enough to report (39%).
CONCLUSIONS: Over half of consumers knew that they could report ADR; however, improved consumer awareness about using digital tools for ADR reporting and increased ADR reporting is needed.
摘要:
本研究旨在调查澳大利亚消费者对药品不良反应(ADR)报告的当前知识和经验,以及他们报告或不报告ADR的原因。重点是使用数字工具进行ADR报告。
方法:对在澳大利亚服药的成年人进行了一项横断面在线调查。使用具有多项选择或Likert量表回答的结构化问卷,参与者可以选择提供自由文本回答并进行面部效度预测。消费者特征,知识,和ADR报告实践使用描述性统计和卡方检验或Fisher精确检验进行分析。
结果:总共544份调查回复被纳入分析。大多数受访者是女性(68%),22%的年龄在65至74岁之间。58%(n=317)的受访者知道他们可以向治疗用品管理局(TGA)报告不良反应,州或地区政府卫生部门,或医疗保健专业人员。四分之三(n=405)的受访者表示他们经历了ADR;其中,36%的人向TGA报告了ADR,州或地区政府卫生部门,或医疗保健专业人员。在报告ADR的人中,58%的人不知道他们可以使用数字工具来报告ADR。不报告的主要原因是他们认为ADR的严重程度不足以报告(39%)。
结论:超过一半的消费者知道他们可以报告ADR;然而,需要提高消费者对使用数字工具进行ADR报告的认识,并增加ADR报告。
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