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津巴布韦一家转诊医院的药品不良反应报告

Adverse drug reactions reporting at a referral hospital in Zimbabwe.

作者信息

Khoza S, Madungwe I, Nyambayo P, Mthethwa J, Chikuni O

机构信息

Department of Clinical Pharmacology, University of Zimbabwe Medical School, P O Box A178, Avondale, Harare, Zimbabwe.

出版信息

Cent Afr J Med. 2004 Nov-Dec;50(11-12):104-7.

PMID:16615658
Abstract

OBJECTIVES

To establish factors influencing voluntary reporting of adverse drug reactions among health workers. A second objective was to establish the level of awareness on adverse drug reaction reporting and attitudes towards the voluntary adverse drug reaction reporting scheme.

DESIGN

Cross sectional descriptive study.

SETTING

Parirenyatwa Hospital, a major referral and teaching hospital in Harare, Zimbabwe.

SUBJECTS

200 health professionals randomly selected from various departments.

MAIN OUTCOME MEASURES

Number of health workers reporting adverse drug reactions; awareness of the adverse drug reaction reporting scheme.

RESULTS

144 (72%) questionnaires were completed. About half (47.2%) of the respondents did not know how to report an adverse drug reaction and 47.1% were unaware of the existence of a formal adverse drug reaction reporting scheme in Zimbabwe. One fifth (20.1%) of the respondents had reported an adverse drug reaction at some point. Two main factors contributing to under-reporting cited by respondents were the poor feedback from the national reporting centre (59%) and inaccessibility of reporting facilities (45.8%). Beliefs that one should only report an adverse drug reaction if certain of causality (46.5%) and that really serious adverse drug reactions are well documented before a drug is marketed (35.4%) could also account for under reporting. However, 75.7%, viewed adverse drug reaction reporting as a professional obligation.

CONCLUSION

Lack of awareness of healthcare professionals to the national (Medicines Control Authority of Zimbabwe) adverse drug reaction voluntary reporting scheme, poor feedback and inaccessibility of reporting facilities are the main factors contributing towards underreporting.

摘要

目的

确定影响卫生工作者自愿报告药品不良反应的因素。第二个目的是确定对药品不良反应报告的认知水平以及对自愿药品不良反应报告计划的态度。

设计

横断面描述性研究。

地点

位于津巴布韦哈拉雷的主要转诊和教学医院帕里伦亚瓦医院。

研究对象

从各个科室随机抽取的200名卫生专业人员。

主要观察指标

报告药品不良反应的卫生工作者人数;对药品不良反应报告计划的认知情况。

结果

共完成144份(72%)问卷。约一半(47.2%)的受访者不知道如何报告药品不良反应,47.1%的人不知道津巴布韦存在正式的药品不良反应报告计划。五分之一(20.1%)的受访者曾在某个时候报告过药品不良反应。受访者提到的导致报告不足的两个主要因素是国家报告中心反馈不佳(59%)和报告设施难以获取(45.8%)。认为只有在确定因果关系时才应报告药品不良反应(46.5%)以及认为真正严重的药品不良反应在药品上市前已有充分记录(35.4%)也可能导致报告不足。然而,75.7%的人认为药品不良反应报告是一项职业义务。

结论

医疗保健专业人员对国家(津巴布韦药品控制局)药品不良反应自愿报告计划缺乏了解、反馈不佳以及报告设施难以获取是导致报告不足的主要因素。

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