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家庭儿科医生的药物警戒知识。意大利的一项调查研究。

Pharmacovigilance knowledge in family paediatricians. A survey study in Italy.

机构信息

Unit of Clinical Pharmacology, CNR Institute of Neuroscience, Department of Biomedical and Clinical Sciences, University Hospital "Luigi Sacco", Università di Milano, 20157 Milan, Italy.

出版信息

Health Policy. 2013 Nov;113(1-2):216-20. doi: 10.1016/j.healthpol.2013.08.006. Epub 2013 Aug 27.

Abstract

Drugs prescription in children correlates with a high risk of developing unknown or rare adverse drug reactions (ADRs). In the absence of appropriate clinical trials in the paediatric population, the spontaneous reporting of suspected ADRs is an important means to promote reasonable warning signals. In this context, family paediatricians (FPs) play a crucial role although a general poor compliance in their ability of reporting of ADR is widely described. To understand the reasons beyond this situation we performed a survey, the first of its kind in Italy, to evaluate FPs knowledge, feeling and compliance in ADR reporting. A total of 552 FPs evenly distributed throughout the Italian territory provided a feedback to the survey. Knowledge of pharmacovigilance (PV) resulted to be poor, mainly due to the absence of adequate training in academy; despite this, the majority of FPs declared to be interested to PV and aware of its positive impact on their clinical practice. Yet, FPs reported a poor compliance to the reporting of ADRs. A very high variability in ADRs reporting however, was observed among the regions, possibly because of variability of regional educational programmes dedicated to PV.

摘要

在儿童中开具药物处方与发生未知或罕见药物不良反应 (ADR) 的风险较高相关。在儿科人群中缺乏适当的临床试验的情况下,疑似 ADR 的自发报告是促进合理警示信号的重要手段。在这种情况下,家庭儿科医生 (FP) 发挥着至关重要的作用,尽管他们报告 ADR 的能力普遍较差。为了了解这种情况背后的原因,我们进行了一项调查,这在意大利是首例,旨在评估 FP 对 ADR 报告的知识、感受和遵守情况。意大利各地共有 552 名 FP 对调查做出了反馈。药物警戒 (PV) 知识较差,主要是由于在学术机构缺乏足够的培训;尽管如此,大多数 FP 表示对 PV 感兴趣,并意识到其对他们的临床实践有积极影响。然而,FP 报告称他们对 ADR 报告的遵守情况较差。然而,各地区之间 ADR 报告的遵守情况存在很大差异,这可能是因为针对 PV 的地区教育计划存在差异。

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