Medical Statistics Team, Section of Population Health, University of Aberdeen, Aberdeen, UK.
Drug Saf. 2010 Sep 1;33(9):775-88. doi: 10.2165/11536510-000000000-00000.
In the UK, spontaneous reporting of suspected adverse drug reactions (ADRs) by healthcare professionals has been in operation since 1964 through the Yellow Card Scheme (YCS). From 2005, patients themselves have been able to submit Yellow Card reports.
To compare patient characteristics, suspected drugs and suspected ADRs reported by patients with those reported by healthcare professionals using the YCS.
Retrospective observational study in the UK.
Participants were patients reported to the Medicines and Healthcare products Regulatory Agency (MHRA), either by themselves, a representative or a healthcare professional, as having one or more suspected ADRs between October 2005 and September 2007. The main outcome measures were ADRs and time taken to report.
In total, 26 129 Yellow Card reports from patients and healthcare professionals were received from the MHRA for the 2-year study period (19.8% patient and 80.2% healthcare professional). More Yellow Card reports were made for female than male patients (p < 0.001). Patients reported a significantly higher number of suspected ADRs per report than healthcare professionals (median [interquartile range {IQR}] of 3 [2-5] vs 2 [1-3], respectively; p < 0.001). A higher proportion of patient reports (16.1%) contained more than one suspect drug than healthcare professional reports (9%; p < 0.001). Healthcare professional reports had a higher proportion of ADRs that caused hospitalization (18.8% vs 12.9%), were life threatening (11.1% vs 6.2%) or caused death (2.6% vs 0.7%) than patient reports (all p < 0.001). Patient reporters took a significantly longer time to report their reaction than healthcare professionals (median [IQR] of 104 [27-463] vs 28 [13-75] days respectively; p < 0.001). Direct comparisons of the seriousness of the ADRs were not possible because of important differences between patient and healthcare professional versions of the Yellow Cards.
This is the first substantial, published study in the UK to compare Yellow Card reports from patients and healthcare professionals. Whilst patients report more suspected ADRs to more suspect drugs than healthcare professionals, healthcare professionals tend to report more serious reactions that result in hospitalization, are life threatening or cause death. Further research is required to investigate the extent to which the extra information from patient reporters contributes to signal identification when assessing drug safety.
自 1964 年以来，英国通过黄卡计划（Yellow Card Scheme，YCS）一直要求医疗保健专业人员自发报告疑似药物不良反应（Adverse Drug Reaction，ADR）。自 2005 年起，患者也可以提交黄卡报告。
比较患者通过黄卡计划报告的自身疑似药物不良反应（ADR）的患者特征、疑似药物和疑似 ADR，与医疗保健专业人员报告的情况。
在英国进行的回顾性观察性研究。
研究参与者是在 2005 年 10 月至 2007 年 9 月期间，通过 MHRA 向药品和保健品管理局（Medicines and Healthcare products Regulatory Agency，MHRA）报告的患者，他们报告自身存在一个或多个疑似 ADR，报告人可以是患者本人、代表或医疗保健专业人员。主要结局指标是 ADR 和报告时间。
在为期 2 年的研究期间，MHRA 共收到 26129 份来自患者和医疗保健专业人员的黄卡报告（19.8%为患者报告，80.2%为医疗保健专业人员报告）。与男性患者相比，女性患者提交的黄卡报告明显更多（p<0.001）。与医疗保健专业人员报告相比，患者报告的疑似 ADR 数量明显更多（中位数[四分位距 {IQR}]为 3[2-5] vs 2[1-3]，p<0.001）。患者报告中包含一种以上可疑药物的比例（16.1%）明显高于医疗保健专业人员报告（9%，p<0.001）。医疗保健专业人员报告中因 ADR 而住院的比例（18.8%）、有生命威胁的比例（11.1%）或导致死亡的比例（2.6%）均明显高于患者报告（均 p<0.001）。与医疗保健专业人员相比，患者报告反应的时间明显更长（中位数[IQR]为 104[27-463] vs 28[13-75]天，p<0.001）。由于黄卡的患者版和医疗保健专业人员版之间存在重要差异，因此无法直接比较 ADR 严重程度。
这是英国首次对患者和医疗保健专业人员的黄卡报告进行的大规模、已发表的比较研究。虽然患者报告的疑似 ADR 涉及的可疑药物比医疗保健专业人员多，但医疗保健专业人员报告的反应往往更严重，会导致住院、有生命威胁或导致死亡。需要进一步研究，以调查患者报告人提供的额外信息在评估药物安全性时对信号识别的贡献程度。
