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瑞典北部地区对药品不良反应报告的态度。

Attitudes to reporting adverse drug reactions in northern Sweden.

作者信息

Bäckström M, Mjörndal T, Dahlqvist R, Nordkvist-Olsson T

机构信息

Division of Clinical Pharmacology, Norrland University Hospital, Umeå, Sweden.

出版信息

Eur J Clin Pharmacol. 2000 Dec;56(9-10):729-32. doi: 10.1007/s002280000202.

DOI:10.1007/s002280000202
PMID:11214784
Abstract

OBJECTIVES

This study was designed to investigate attitudes of general practitioners (GPs) and hospital physicians in Sweden towards spontaneous reporting of adverse drug reactions (ADRs).

METHOD

Two areas in the northern region of Sweden were selected for the study. A knowledge and attitude questionnaire followed by a reminder letter 2 weeks later was addressed to all GPs and hospital physicians in the study areas.

RESULT

The total response rate from the study areas was 748 of the 1274 questionnaires sent out (58.7%). Of those who responded, 236 were GPs, 433 were hospital physicians and 79 had other positions. Of the responders, 252 stated that they had never reported any ADR and 488 that they had reported at least once in their career. Issues that came out as important in the decision to report or not to report were whether the reaction was considered well-known or not, the severity of the reaction, hesitance to report only on suspicion, lack of knowledge of existing rules, giving priority to other matters and lack of time to report ADRs. Only minor differences in these regards were observed between male and female physicians.

CONCLUSION

Our investigation shows that the physicians in northern Sweden have a fairly good knowledge about the existing rules for reporting ADRs in Sweden. However, the attitudes leave room for considerable under-reporting due to matters related mainly to the medical impact of the reaction and of reporting it, but also to the scientific "paradox" of reporting only on suspicion and of course due to lack of time in the health care setting.

摘要

目的

本研究旨在调查瑞典全科医生(GPs)和医院医生对药品不良反应(ADR)自发报告的态度。

方法

选择瑞典北部地区的两个区域进行研究。向研究区域内的所有全科医生和医院医生发放一份知识与态度问卷,并在两周后发送提醒信。

结果

在发出的1274份问卷中,研究区域的总回复率为748份(58.7%)。在回复者中,236人是全科医生,433人是医院医生,79人担任其他职位。在回复者中,252人表示他们从未报告过任何药品不良反应,488人表示他们在职业生涯中至少报告过一次。在决定报告或不报告时,被认为重要的问题包括反应是否被认为是常见的、反应的严重程度、仅基于怀疑而不愿报告、对现有规则缺乏了解、优先处理其他事务以及缺乏时间报告药品不良反应。在这些方面,男性和女性医生之间仅观察到细微差异。

结论

我们的调查表明,瑞典北部的医生对瑞典现有的药品不良反应报告规则有相当好的了解。然而,由于主要与反应的医学影响及其报告相关的问题,以及仅基于怀疑进行报告的科学“悖论”,当然还有医疗保健环境中缺乏时间,这些态度使得漏报情况相当严重。

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