Institute of Psychology, Health and Society, University of Liverpool, Liverpool, UK.
Br J Clin Pharmacol. 2013 Apr;75(4):1109-17. doi: 10.1111/j.1365-2125.2012.04441.x.
To investigate parents' views and experiences of direct reporting of a suspected ADR in their child.
We audio-recorded semi-structured qualitative interviews with parents of children with suspected ADRs. Our sample included parents with (n = 17) and without (n = 27) previous experience of submitting a Yellow Card.
Parents in both groups described poor awareness of the Yellow Card Scheme. Parents who had participated in the Yellow Card Scheme were generally happy to report their child's ADR via the Scheme and valued the opportunity to report concerns independently of health practitioners. They expressed motivations for reporting that have not previously been described linked to the parental role, including how registering a concern about a medicine helped to resolve uncomfortable feelings about their child's ADR. Parents who had not previously submitted a Yellow Card expressed uncertainty about the legitimacy of their involvement in reporting and doubts about the value of the information that they could provide.
Promoting wider participation in pharmacovigilance schemes will depend on raising public awareness. Additionally, our findings point to the need to empower lay people to submitting reports and to reassure them about the value of their reports.
调查父母对其子女疑似不良反应直接报告的看法和经验。
我们对有（n=17）和无（n=27）既往提交黄卡经验的疑似不良反应儿童的父母进行了半结构化定性访谈，并对访谈进行了录音。
两组父母均对黄卡计划的知晓度较差。参加过黄卡计划的父母普遍乐于通过该计划报告其子女的不良反应，并重视有机会独立于医疗保健提供者报告他们的担忧。他们表达了报告的动机，这些动机与父母的角色有关，包括记录对药物的担忧有助于消除他们对子女不良反应的不适感受。以前没有提交过黄卡的父母对自己参与报告的合法性表示不确定，对他们可以提供的信息的价值表示怀疑。
促进更广泛地参与药物警戒计划将取决于提高公众意识。此外，我们的研究结果表明，有必要赋予非专业人员提交报告的权力，并让他们相信他们的报告的价值。
