Views on the Development and Use of a New Digital Adverse Drug Event Reporting Platform in Australia: A Qualitative Study.

IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Drug Safety Pub Date : 2024-11-02 DOI:10.1007/s40264-024-01489-3
Eyob Alemayehu Gebreyohannes, Christopher Thornton, Myra Thiessen, Sieta T de Vries, Gretchen Coombs, Indae Hwang, Renly Lim
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Abstract

Background: Reporting of adverse drug events (ADEs) to regulatory authorities remains low, particularly among consumers.

Objectives: To explore stakeholders' views on the development and use of a digital platform to improve ADE reporting by consumers to the regulatory authority in Australia, i.e., the Therapeutic Goods Administration.

Methods: A qualitative study was conducted using semi-structured interviews, focus group discussions (FGDs), and co-design workshops with consumers, healthcare professionals (HCPs), and regulators. The interview recordings were transcribed verbatim, coded, and analysed thematically according to the Capability, Opportunity, Motivation, Behaviour model. Findings of the FGDs and co-design workshops were incorporated to enhance and complement the insights gathered from the interviews.

Results: A total of 39 participants took part in the study (54 % consumers, 41 % HCPs, and 5 % regulators). Uncovered themes related to ADE reporting in general were: difficulty recognizing ADEs and health literacy, awareness about reporting ADEs (Capability); visibility of ADE reporting, professionals' views on consumer ADE reporting, consumer education (Opportunity); the common good, benefit to the reporter, identifying ADEs worth reporting, and concern about reporting (Motivation). Additional identified themes specific to a new digital platform were: physical abilities (Capability); features that facilitate intuitive use, convenience and accessibility, user experience, integration with existing systems, trust, sharing experiences with others (Opportunity); and concern about using a reporting platform, and feedback loop (Motivation).

Conclusions: A cross-section of attitudes and values were obtained regarding ADE reporting in general and a new ADE reporting digital platform for consumers in Australia, which will inform its development, implementation and evaluation.

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关于澳大利亚新数字药物不良事件报告平台的开发和使用的观点:定性研究。
背景:向监管机构报告药物不良事件(ADE)的比例仍然很低,尤其是消费者:探讨利益相关者对开发和使用数字平台以改善消费者向澳大利亚监管机构(即治疗用品管理局)报告药物不良事件的看法:采用半结构化访谈、焦点小组讨论 (FGD) 以及与消费者、医疗保健专业人员 (HCP) 和监管机构共同设计研讨会的方式开展了一项定性研究。访谈记录被逐字转录、编码,并根据能力、机会、动机、行为模型进行主题分析。此外,还纳入了专题小组讨论和共同设计研讨会的结果,以加强和补充从访谈中收集到的见解:共有 39 人参加了研究(54 % 为消费者,41 % 为保健医生,5 % 为监管人员)。发现的与ADE报告相关的主题包括:ADE识别困难和健康知识普及、对ADE报告的认识(能力);ADE报告的可见性、专业人士对消费者ADE报告的看法、消费者教育(机会);共同利益、对报告者的益处、识别值得报告的ADE以及对报告的担忧(动机)。针对新数字平台确定的其他主题包括:身体能力(能力);便于直观使用的功能、便利性和可访问性、用户体验、与现有系统的整合、信任、与他人分享经验(机会);以及对使用报告平台和反馈回路的担忧(动机):我们获得了关于一般 ADE 报告和澳大利亚消费者新 ADE 报告数字平台的各种态度和价值观,这将为其开发、实施和评估提供参考。
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来源期刊
Drug Safety
Drug Safety 医学-毒理学
CiteScore
7.60
自引率
7.10%
发文量
112
审稿时长
6-12 weeks
期刊介绍: Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.
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