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波兰和德国儿科神经科医生的药物警戒实践。

Pharmacovigilance practice among pediatric neurologists from Poland and Germany.

机构信息

Department of Pharmacoeconomics and Social Pharmacy, Poznan University of Medical Sciences, Rokietnicka 7 St, 60-806, Poznań, Poland.

Department of Neurology, Martin-Luther-University Hospital Halle- Wittenberg, Halle, Germany.

出版信息

BMC Med Educ. 2023 Aug 1;23(1):547. doi: 10.1186/s12909-023-04542-4.

Abstract

OBJECTIVES

To compare the pediatric neurologists' knowledge, practice, and barriers to the pharmacovigilance (PV) process in Poland and Germany.

METHODS

The research tool was an online anonymous questionnaire on Google Forms e-mailed to pediatric neurologists from Poland and Germany.

RESULTS

The questionnaires were handed out to 830 pediatric neurologists and 371 expressed their consent to participate in the study. Most of the neurologists were familiar with the definition of PV and adverse drug reactions (ADRs). Only 34.10% of pediatric neurologists from Poland, and 38.88% from Germany believe that many ADRs are preventable and almost most of them believe it is necessary to report ADRs from children with epilepsy. Unfortunately, in opposite to this knowledge, only 37.79% of respondents from Poland and 40.32% from Germany felt co-responsible for reporting ADRs. The main reason for the neurologists not to report ADRs was a conviction that reporting ADRs would be an additional burden generating extra work.

CONCLUSION

There is no big difference between the practice of PV by pediatric neurologists in Poland and Germany. System-regulated PV stabilization in the country translates into the practice of maintaining PV. Monitoring the safety of pharmacotherapy and knowledge of risks associated with ADRs should be included in the curricula of academic neurologics courses.

摘要

目的

比较波兰和德国儿科神经科医生在药物警戒(PV)过程中的知识、实践和障碍。

方法

研究工具是一份在线匿名问卷,通过电子邮件发送给波兰和德国的儿科神经科医生,采用 Google 表单进行。

结果

向 830 名儿科神经科医生分发了问卷,其中 371 名表示同意参与研究。大多数神经科医生熟悉 PV 和药物不良反应(ADR)的定义。只有 34.10%的波兰儿科神经科医生和 38.88%的德国儿科神经科医生认为许多 ADR 是可以预防的,而且几乎大多数人认为有必要报告来自癫痫儿童的 ADR。不幸的是,与这种认知相反,只有 37.79%的波兰受访者和 40.32%的德国受访者认为自己对报告 ADR 负有共同责任。神经科医生不报告 ADR 的主要原因是他们认为报告 ADR 将是一项额外的负担,会产生额外的工作。

结论

波兰和德国儿科神经科医生在 PV 实践方面没有太大区别。国家规范的 PV 稳定系统转化为维持 PV 的实践。应在学术神经病学课程的课程中纳入药物治疗安全性监测和与 ADR 相关风险的知识。

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