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报告、处理和全科医生对药物不良反应的主观重要性:一项探索性横断面调查。

Reporting, handling, and subjective importance of adverse drug reactions among general practitioners: an exploratory cross-sectional survey.

机构信息

Department of Psychiatry and Psychotherapy III, University Clinic of Ulm, Ulm, Germany.

Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm, Germany.

出版信息

Expert Opin Drug Saf. 2021 Aug;20(8):979-985. doi: 10.1080/14740338.2021.1933430. Epub 2021 Jun 9.

DOI:10.1080/14740338.2021.1933430
PMID:34014779
Abstract

: Interventions for improving reporting and management of adverse drug reactions (ADRs) need regular evaluations of attitude and knowledge of health care professionals regarding pharmacovigilance.: An exploratory survey among general practitioners in Germany was conducted.: We interviewed 302 individuals (participation rate 34.3%; mean age 54 yrs; 37.1% female). Underreporting was prevalent in the sample (only 16.6% had reported an ADR in 2015; average total number of ADR-reports was 5). We found awareness of the importance of pharmacovigilance and ADRs, information deficits (43% were not aware of the obligation to report ADRs), and several uncertainties regarding the detection and reporting of ADRs. The participants rated the German ADR reporting system as satisfactory (mean grade 3.7 ± 1.2) and criticized the expenditure of time (63.6%) and the overall complexity (47.4%). To increase the motivation to report ADRs, the majority requested the possibility to report by telephone (61.3%), feedback after reporting (49.3%), telephone consultations (47.4%), and more education and training in pharmacovigilance (31.1%), also during medical school (25.8%).: We found evidence of objective and subjective need for further (mandatory) education and training in pharmacovigilance, already during medical school. Our results point to some shortcomings of the German pharmacovigilance system.

摘要

干预措施需要定期评估医疗保健专业人员对药物警戒的态度和知识,以改善药物不良反应(ADR)的报告和管理。在德国,我们对全科医生进行了一项探索性调查。我们采访了 302 人(参与率为 34.3%;平均年龄 54 岁;37.1%为女性)。在样本中普遍存在漏报现象(只有 16.6%的人在 2015 年报告了 ADR;平均 ADR 报告数量为 5 份)。我们发现,他们意识到药物警戒和 ADR 的重要性,但也存在信息不足的问题(43%的人不知道报告 ADR 的义务),并且对 ADR 的检测和报告存在一些不确定因素。参与者对德国 ADR 报告系统的评价为满意(平均等级为 3.7±1.2),并批评了报告时间(63.6%)和整体复杂性(47.4%)的问题。为了提高报告 ADR 的积极性,大多数人要求可以通过电话报告(61.3%)、报告后获得反馈(49.3%)、电话咨询(47.4%),并增加药物警戒方面的教育和培训(31.1%),包括在医学院期间(25.8%)。我们发现,在医学院期间,已经有客观和主观的需要进一步(强制)进行药物警戒教育和培训。我们的结果指出了德国药物警戒系统的一些不足之处。

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