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药品不良反应报告:德国药学专业人员的贡献、知识与认知

Reporting adverse drug reactions: contribution, knowledge and perception of German pharmacy professionals.

作者信息

Laven Anna, Schmitz Katharina, Franzen Wilhelm-Hubertus

机构信息

Pharmabrain GmbH, Research and Training Center, Schumannstr. 7b, 10117, Berlin, Germany.

Takeda Pharma Vertrieb GmbH & Co. KG, Jaegerstr. 27, 10117, Berlin, Germany.

出版信息

Int J Clin Pharm. 2018 Aug;40(4):842-851. doi: 10.1007/s11096-018-0671-3. Epub 2018 Jun 16.

Abstract

Background The detection, assessment and prevention of adverse drug reactions along the product's life cycle is known as pharmacovigilance. German pharmacists are obliged by law to conduct pharmacovigilance measures, a specific training is not required. Objectives To assess the knowledge, contribution and perception of German pharmacy professionals regarding pharmacovigilance activities, in order to identify their needs to report better on the issue. Setting A semi-quantitative survey among German pharmacy professionals was conducted in November 2017. Method A questionnaire with 20 questions was developed and distributed to pharmacy professionals in four different German regions. Main outcome measures To assess the knowledge the number of right answered questions were examined; for perception a six-point-Likert was used and for contribution, yes or no questions. Results The participation ratio was 64.5% (n = 127). Nearly half of the participants (47.2%, n = 60) stated that they had already reported adverse drug reactions. Regarding the knowledge questions, there was neither a statistically significant difference between the correct answers of pharmacists and pharmacy technical assistents (p = 0.7209), nor between the different regions (p > 0.5054). For better reporting, the participants recommended better training, shorter forms to fill in and/or a contact person to call. Conclusion For the successful integration of pharmacovigilance reporting in daily practice, we suggest the following: (1) A structured, mandatory training of the pharmacy team. (2) The preparation of a standard operating procedure for the pharmacy or its integration into the pharmacy software.

摘要

背景

在产品生命周期内对药物不良反应进行检测、评估和预防被称为药物警戒。德国药剂师依法有义务开展药物警戒措施,无需特定培训。

目的

评估德国药学专业人员对药物警戒活动的知识、贡献和认知,以确定他们在该问题上更好报告的需求。

背景

2017年11月对德国药学专业人员进行了一项半定量调查。

方法

编制了一份包含20个问题的问卷,并分发给德国四个不同地区的药学专业人员。

主要观察指标

通过检查正确回答问题的数量来评估知识;使用六点李克特量表评估认知,使用是或否问题评估贡献。

结果

参与率为64.5%(n = 127)。近一半的参与者(47.2%,n = 60)表示他们已经报告过药物不良反应。关于知识问题,药剂师和药学技术助理的正确答案之间没有统计学显著差异(p = 0.7209),不同地区之间也没有(p > 0.5054)。为了更好地报告,参与者建议提供更好的培训、填写更简短的表格和/或有联系人可供致电。

结论

为了在日常实践中成功整合药物警戒报告,我们建议如下:(1)对药房团队进行结构化的强制性培训。(2)编写药房的标准操作程序或将其整合到药房软件中。

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