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[关于是否向荷兰国家监测系统报告药物副作用的原因]

[Reasons to report or not report side effects of drugs to the national monitoring system in the Netherlands].

作者信息

van Riemsdijk M M, Herings R M, Rawlins M D, Stricker B H

机构信息

Inspectie voor de Gezondheidszorg, sectie Geneesmiddelenbewaking, Rijswijk.

出版信息

Ned Tijdschr Geneeskd. 1995 Nov 11;139(45):2306-8.

PMID:7501063
Abstract

OBJECTIVE

To assess the awareness of medical practitioners in the Netherlands regarding the national voluntary reporting scheme for adverse reactions to drugs, and the reasons for non-reporting.

DESIGN

Questionnaire.

SETTING

Netherlands Centre for Monitoring of Adverse Reactions to Drugs.

METHOD

A questionnaire was sent to a random sample of 500 practitioners aged under 65 in the database of the Dutch Inspectorate for Health Care.

RESULTS

Of the 500 questionnaires 265 (53%) were returned and completely filled in. Sixty-seven (25%) practitioners had reported a suspected adverse reaction on one or several occasions during their practising career; 229 (86%) would report a serious adverse reaction, 190 (72%) an unknown one, 185 (70%) an adverse reaction to a new product, and 83 (31%) a proven adverse reaction. Almost 20% said they had had difficulties reporting because they could not find the telephone number or reporting forms. Forty practitioners (15%) claimed that they were too busy to report adverse reactions. Almost all practitioners (94%) were aware of the fact that the reporting scheme serves the early detection of unknown adverse reactions.

摘要

目的

评估荷兰执业医师对国家药品不良反应自愿报告计划的知晓情况以及未报告的原因。

设计

问卷调查。

地点

荷兰药品不良反应监测中心。

方法

向荷兰医疗保健监察局数据库中500名65岁以下的执业医师随机抽样发送问卷。

结果

500份问卷中,265份(53%)被退回并填写完整。67名(25%)执业医师在其职业生涯中曾有过一次或多次报告疑似不良反应;229名(86%)会报告严重不良反应,190名(72%)会报告不明不良反应,185名(70%)会报告对新产品的不良反应,83名(31%)会报告已证实的不良反应。近20%的人表示他们在报告时遇到困难,因为找不到电话号码或报告表格。40名执业医师(15%)声称他们太忙而无法报告不良反应。几乎所有执业医师(94%)都知道报告计划有助于早期发现不明不良反应。

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