Evaluation of patient reporting of adverse drug reactions to the UK 'Yellow Card Scheme': literature review, descriptive and qualitative analyses, and questionnaire surveys
Evaluation of patient reporting of adverse drug reactions to the UK 'Yellow Card Scheme': literature review, descriptive and qualitative analyses, and questionnaire surveys
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DOI：
10.3310/hta15200
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发表时间：
2011-05-01
影响因子：
3.6
通讯作者：
Watson, M. C.
中科院分区：
文献类型：
--
作者：
Avery, A. J.;Anderson, C.;Watson, M. C.
背景：通过药物警戒监测药物不良反应(ADRs)对患者安全至关重要。自发报告ADRs是药物警戒的一种方法，在英国，这是通过黄牌计划(YCS)进行的。黄牌报告通过邮寄、电话或互联网提交给药品和保健品监管机构(MHRA)。MHRA以电子方式记录和审查提交的信息，以便发现重要的安全问题。虽然以前的研究表明，患者和医疗保健专业人员(HCP)报告中报告的药物类型和反应存在差异，但对患者报告的药物警戒影响知之甚少。关于患者/消费者对可疑ADR报告的看法和经验的研究也很少。目的：通过分析英国YCS的疑似ADR报告，并比较患者和HCP的报告，评估患者报告ADR的药物警戒作用。(2)黄卡报告的描述性分析；(3)黄卡报告的信号生成分析；(4)黄卡报告的定性分析；(5)黄卡患者报告的问卷调查；(6)电话访谈的定性分析；(7)焦点群体的定性分析和患者YCS的可用性测试；对2005年10月至2007年9月期间提交黄牌报告的5180名患者和20949名初级卫生保健人员进行全国综合电话调查。问卷调查的受访者(n=1362)。参加焦点小组和可用性测试会议(n=40)。国家综合性电话调查(n=2028)。地点：文献综述包括来自世界各地的英语研究。所有其他部分包括来自英国的人群；综合调查仅限于英国。干预：无。主要结果衡量标准：患者报告的特征：报告的药物类型和疑似ADR；报告的严重性；以及报告的内容。患者报告和HCP报告对信号产生的相对贡献。有耐心的记者的观点和经验。公众对YCS的意见，包括方便使用和采用不同的病人报告方式。公众对青年管委会的认识。结果：与HCP相比，YCS的患者报告每份报告中疑似ADR的中位数更高，并更详细地描述反应。被归类为“严重”的报告所占比例相似；报告的药物和反应模式不同。患者报告对反应的描述比来自HCP的报告更丰富，并且更经常地注意到ADR对患者生活的影响。合并患者和HCP报告产生了比单独HCP报告更多的潜在信号；当与患者报告结合时，“仅HCP”数据集中的一些潜在信号丢失，但比获得的信号少；将患者报告添加到HCP报告中发现了47个以前未包括在“产品特征摘要”中的新的“严重”反应。大多数耐心的记者发现做报道相当容易，尽管有人建议对该计划进行改进，包括加大宣传力度，重新设计基于网络和纸质的报道系统。在公众中，8.5%的人在2009年知道YCS。结论：患者报告的疑似ADRs通过报告不同于HCP报告的药物类型和反应，产生新的潜在信号，以及足够详细的描述可疑ADR，提供可能的因果关系和对患者生活的影响，从而增加药物警戒的价值。这些发现表明，进一步推动患者向青年管治中心报告是合理的，并改进现有的报告系统。按照优先顺序，未来的工作应包括以下方面的进一步调查：(1)长期研究中患者报告的药物警戒影响；(2)患者和HCP报告的信号产生分析的最佳方法；(3)ADRs对患者生活的影响方面的负担；(4)HCP对患者报告ADRs的知识和态度；(5)利用患者的ADR报告帮助其他患者和正在寻求有关ADR患者经历的信息的HCP的价值；以及(6)加强宣传和/或加强举报制度对病人黄卡举报的数量和类型的影响。
Background: The monitoring of adverse drug reactions (ADRs) through pharmacovigilance is vital to patient safety. Spontaneous reporting of ADRs is one method of pharmacovigilance, and in the UK this is undertaken through the Yellow Card Scheme (YCS). Yellow Card reports are submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) by post, telephone or via the internet. The MHRA electronically records and reviews information submitted so that important safety issues can be detected. While previous studies have shown differences between patient and healthcare professional (HCP) reports for the types of drugs and reactions reported, relatively little is known about the pharmacovigilance impact of patient reports. There have also been few studies on the views and experiences of patients/consumers on the reporting of suspected ADRs.Objectives: To evaluate the pharmacovigilance impact of patient reporting of ADRs by analysing reports of suspected ADRs from the UK YCS and comparing reports from patients and HCPs. To elicit the views and experiences of patients and the public about patient reporting of ADRs.Design: (1) Literature review and survey of international experiences of consumer reporting of ADRs; (2) descriptive analysis of Yellow Card reports; (3) signal generation analysis of Yellow Card reports; (4) qualitative analysis of Yellow Card reports; (5) questionnaire survey of patients reporting on Yellow Cards; (6) qualitative analysis of telephone interviews with patient reporters to the scheme; (7) qualitative analysis of focus groups and usability testing of the patient YCS; and (8) national omnibus telephone survey of public awareness of the YCS.Participants: Patients (n = 5180) and HCPs (n,= 20,949) submitting Yellow Card reports from October 2005 to September 2007. Respondents to questionnaire survey (n = 1 362). Participants at focus groups and usability testing sessions (n = 40). National omnibus telephone survey (n = 2028).Setting: The literature review included studies in English from across the world. All other components included populations from the UK; the omnibus survey was restricted to Great Britain.Interventions: None.Main outcome measures: Characteristics of patient reports: types of drug and suspected ADR reported; seriousness of reports; and content of reports. The relative contributions of patient reports and of HCP reports to signal generation. Views and experiences of patient reporters. Views of members of the public about the YCS, including user-friendliness and usability of different ways of patient reporting. Public awareness of the YCS. Suggestions for improving patient reporting to the YCS.Results: Compared with HCPs, patient reports to the YCS contained a higher median number of suspected ADRs per report, and described reactions in more detail. The proportions of reports categorised as 'serious' were similar; the patterns of drugs and reactions reported differed. Patient reports were richer in their descriptions of reactions than those from HCPs, and more often noted the effects of ADRs on patients' lives. Combining patient and HCP reports generated more potential signals than HCP reports alone; some potential signals in the 'HCP-only' data set were lost when combined with patient reports, but fewer than those gained; the addition of patient reports to HCP reports identified 47 new 'serious' reactions not previously included in 'Summaries of Product Characteristics'. Most patient reporters found it fairly easy to make reports, although improvements to the scheme were suggested, including greater publicity and the redesign of web- and paper-based reporting systems. Among members of the public, 8.5% were aware of the YCS in 2009.Conclusions: Patient reporting of suspected ADRs has the potential to add value to pharmacovigilance by reporting types of drugs and reactions different from those reported by HCPs; generating new potential signals; and describing suspected ADRs in enough detail to provide useful information on likely causality and impact on patients' lives. These findings suggest that further promotion of patient reporting to the YCS is justified, along with improvements to existing reporting systems. In order of priority, future work should include further investigation of (1) the pharmacovigilance impact of patient reporting in a longer-term study; (2) the optimum approach to signal generation analysis of patient and HCP reports; (3) the burden of ADRs in terms of impact on patients' lives; (4) the knowledge and attitudes of HCPs towards patient reporting of ADRs; (5) the value of using patient reports of ADRs to help other patients and HCPs who are seeking information on patient experiences of ADRs; and (6) the impact of increasing publicity and/or enhancements to reporting systems on the numbers and types of Yellow Card reports from patients.