Adverse drug reaction reporting by patients in the Netherlands - Three years of experience
Adverse drug reaction reporting by patients in the Netherlands - Three years of experience
复制标题
DOI：
10.2165/00002018-200831060-00006
复制
发表时间：
2008-01-01
期刊：
影响因子：
4.2
通讯作者：
van Grootheest, Kees
中科院分区：
文献类型：
--
作者：
de Langen, Joyce;van Hunsel, Florence;van Grootheest, Kees
背景：已经讨论了患者向自发报告系统报告的药物不良反应（ADR）的可接受性。在真实的生活中缺乏患者报告的经验是这场辩论的主要缺点之一。本研究涵盖了3年的日常实践中患者报告经验。我们将患者报告与医疗保健专业人员的报告进行了比较。虽然患者有机会在几个国家报告ADR，但文献中几乎没有关于患者报告在实践中的贡献的报道。据我们所知，本文是第一篇描述患者报告作为自发报告系统的一部分的长期经验的文章。收到的报告数量、报告者的年龄和性别、最常报告的药物特征和ADR特征（最常报告的ADR、严重性、结局）（2004年4月至2007年4月）患者报告和医疗保健专业人员的报告进行了比较。在这3年期间，荷兰药物警戒中心Lareb收到了2522份直接来自患者的报告，涉及5401起ADR。在同一时期，医疗保健专业人员提交了10 635份报告，涉及16 722起ADR。发现患者和医疗保健专业人员之间报告的ADR的严重性和结局类别存在差异。相反，患者报告和医疗保健专业人员的报告之间的相似之处，发现在年龄，性别，最常报告的ADR和最常报告的drugs.Interpretation：我们的研究清楚地强调，从患者的ADR报告和医疗保健专业人员的报告之间存在有价值的差异。患者和医疗保健专业人员的解读差异可能导致观察到的报告ADR的严重性和结局差异。然而，在最常报告的ADR和最常报告的药物方面，患者报告和医疗保健专业人员报告之间的相似性是惊人的。经过3年的患者报告经验，我们得出结论，自发报告系统中的患者报告是可行的，并且它显著有助于可靠的药物警戒。
Background: There has been discussion about the acceptance of adverse drug reactions (ADRs) reported by patients to spontaneous reporting systems. Lack of experience with patient reporting in real life was one of the main drawbacks in this debate. This study covers 3 years of experience with patient reporting in daily practice. We compared patient reports with reports from healthcare professionals. Although patients have the opportunity to report ADRs in several countries, little is published in the literature about the contribution that patient reports have in practice. To our knowledge, this paper is the first to describe long-term experiences with patient reporting as part of a spontaneous reporting system.Methods: The number of reports received, age and sex of the reporters, characteristics of the most frequently reported drugs and characteristics of the ADRs (most frequently reported ADRs, seriousness, outcome) in a 3-year period (April 2004-April 2007) were compared between patient reports and reports from healthcare professionals.Findings: During this 3-year period, the Netherlands Pharmacovigilance Centre Lareb received 2522 reports directly from patients, concerning 5401 ADRs. In the same period, healthcare professionals submitted 10 635 reports, concerning 16 722 ADRs. Differences were found in the categories of seriousness and outcome of the reported ADRs between patients and healthcare professionals. Conversely, similarities between patient reports and reports from healthcare professionals were found in age, sex, most frequently reported ADRs and most frequently reported drugs.Interpretation: Our study highlights clearly that valuable differences between ADR reports from patients and reports from healthcare professionals exist. Differences in interpretation by patients and healthcare professionals may cause the observed disparities in seriousness and outcome of reported ADRs. However, the similarities between patient reports and reports from healthcare professionals in most frequently reported ADRs and most frequently reported drugs are striking. After 3 years of experience with patient reporting, we conclude that patient reporting in spontaneous reporting systems is feasible and that it contributes significantly to a reliable pharmacovigilance.