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中国武汉医护人员对药品不良反应报告的认知与态度

Awareness and attitudes of healthcare professionals in Wuhan, China to the reporting of adverse drug reactions.

作者信息

Li Qing, Zhang Su-min, Chen Hua-ting, Fang Shi-ping, Yu Xin, Liu Dong, Shi Lü-yuan, Zeng Fan-dian

机构信息

Institute of Clinical Pharmacology, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.

出版信息

Chin Med J (Engl). 2004 Jun;117(6):856-61.

Abstract

BACKGROUND

A voluntary procedure for reporting adverse drug reactions (ADRs) was formally put in place in 1989. However, only a small proportion of ADR reports are actually forwarded to the national monitoring center. To identify the reasons for underreporting, the authors investigated the awareness and attitudes of healthcare professionals (doctors, nurses, and administrators) toward the ADR system in China. In addition, the authors sought to formulate approaches to improve the current ADR reporting system.

METHODS

Structured interviews were carried out in 16 hospitals selected from 27 municipal hospitals in Wuhan, Hubei Province, China. A questionnaire survey of a stratified random sample of approximately 15% of healthcare professionals in each selected hospital was conducted during February to March 2003.

RESULTS

The response rate of this survey was 85%. One thousand six hundred and fifty-three questionnaires were used in the final analysis. Only 2.7% of the healthcare professionals had a correct understanding to the definition of ADR. Eighty-nine point two percent of the healthcare professionals had encountered ADRs. Ninety-four percent of them were aware of the need to report these to the ADR monitoring center. However, only 28.5% of doctors, 22.8% of nurses, and 29.7% of administrators actually submitted a report. For the most part, they reported ADRs to the hospital pharmacy (66.0%), to other departments in the hospital (72.5%), and to the pharmaceutical industry (23.0%), rather than to the national monitoring center (2.9%) or regional monitoring center (9.5%). Severe or rare ADRs and ADRs to new products were generally perceived to be significant enough to report. Sixty-two point one percent of the healthcare professionals had encountered ADRs, yet not reported them to anybody. The major reasons for not reporting included no knowledge of the reporting procedure (71.4%), unavailability of the reporting center mailing address (67.9%), unavailability of the ADR report form (60.4%), lack of knowledge of the existence of a national ADR reporting system (52.2%), and belief that the ADR in question was already well known (44.1%).

CONCLUSIONS

Healthcare professionals in Wuhan, China have little basic knowledge of ADR and of the voluntary reporting system. The main reasons for underreporting were lack of basic knowledge about ADRs and the voluntary reporting procedure. Education and training of healthcare professionals is needed to improve the current ADR reporting system.

摘要

背景

药品不良反应(ADR)自愿报告程序于1989年正式实施。然而,实际转发至国家监测中心的ADR报告仅占一小部分。为查明报告率低的原因,作者调查了中国医疗保健专业人员(医生、护士和管理人员)对ADR系统的认知和态度。此外,作者试图制定方法以改进当前的ADR报告系统。

方法

从中国湖北省武汉市27家市级医院中选取16家医院进行结构化访谈。2003年2月至3月期间,对每家所选医院约15%的医疗保健专业人员进行分层随机抽样问卷调查。

结果

本次调查的回复率为85%。最终分析采用了1653份问卷。只有2.7%的医疗保健专业人员对ADR的定义有正确理解。89.2%的医疗保健专业人员曾遇到过ADR。其中94%的人意识到需要向ADR监测中心报告这些情况。然而,实际提交报告的医生仅占28.5%,护士占22.8%,管理人员占29.7%。在大多数情况下,他们向医院药房报告ADR(66.0%),向医院其他科室报告(72.5%),向制药行业报告(23.0%),而不是向国家监测中心报告(2.9%)或地区监测中心报告(9.5%)。严重或罕见的ADR以及新产品的ADR通常被认为有足够的重要性进行报告。62.1%的医疗保健专业人员曾遇到过ADR,但未向任何人报告。未报告的主要原因包括不了解报告程序(71.4%)、没有报告中心的邮寄地址(67.9%)、没有ADR报告表(60.4%)、不知道国家ADR报告系统(52.2%)以及认为所涉ADR已广为人知(44.1%)。

结论

中国武汉的医疗保健专业人员对ADR和自愿报告系统的基本知识了解甚少。报告率低的主要原因是缺乏关于ADR和自愿报告程序的基本知识。需要对医疗保健专业人员进行教育和培训,以改进当前的ADR报告系统。

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