Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, 's-Hertogenbosch, the Netherlands.
Eur J Clin Pharmacol. 2010 Nov;66(11):1143-50. doi: 10.1007/s00228-010-0865-7. Epub 2010 Jul 24.
The aim of this study was to quantify the reasons and opinions of patients who reported adverse drug reactions (ADRs) in the Netherlands to a pharmacovigilance centre.
A web-based questionnaire was sent to 1370 patients who had previously reported an ADR to a pharmacovigilance centre. The data were analysed using descriptive statistics, χ(2) tests and Spearman's correlation coefficients.
The response rate was 76.5% after one reminder. The main reasons for patients to report ADRs were to share their experiences (89% agreed or strongly agreed), the severity of the reaction (86% agreed or strongly agreed to the statement), worries about their own situation (63.2% agreed or strongly agreed) and the fact the ADR was not mentioned in the patient information leaflet (57.6% agreed or strongly agreed). Of the patient-responders, 93.8% shared the opinion that reporting an ADR can prevent harm to other people, 97.9% believed that reporting contributes to research and knowledge, 90.7% stated that they felt responsible for reporting an ADR and 92.5% stated that they will report a possible ADR once again in the future.
The main motives for patients to report their ADRs to a pharmacovigilance centre were the severity of the ADR and their need to share experiences. The high level of response to the questionnaire shows that patients are involved when it comes to ADRs and that they are also willing to share their motivations for and opinions about the reporting of ADRs with a pharmacovigilance centre.
本研究旨在量化向药物警戒中心报告不良反应(ADR)的荷兰患者的原因和意见。
向曾向药物警戒中心报告过 ADR 的 1370 名患者发送了一份基于网络的调查问卷。使用描述性统计、卡方检验和斯皮尔曼相关系数分析数据。
一轮提醒后,回复率为 76.5%。患者报告 ADR 的主要原因是分享他们的经验(89%的人同意或强烈同意)、反应的严重程度(86%的人同意或强烈同意这一说法)、对自身状况的担忧(63.2%的人同意或强烈同意)以及患者信息传单中未提及 ADR(57.6%的人同意或强烈同意)。在患者应答者中,93.8%的人认为报告 ADR 可以防止对其他人造成伤害,97.9%的人认为报告有助于研究和知识,90.7%的人表示他们有责任报告 ADR,92.5%的人表示将来会再次报告可能的 ADR。
患者向药物警戒中心报告 ADR 的主要动机是 ADR 的严重程度和他们分享经验的需求。对调查问卷的高回应率表明,患者在 ADR 方面参与度很高,并且他们也愿意与药物警戒中心分享他们报告 ADR 的动机和意见。