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药物不良反应报告不足:爱尔兰医生的态度

Underreporting of adverse drug reactions: attitudes of Irish doctors.

作者信息

Williams D, Feely J

机构信息

Department of Pharmacology and Therapeutics, Trinity Centre for Health Sciences, St. James's Hospital, Dublin.

出版信息

Ir J Med Sci. 1999 Oct-Dec;168(4):257-61. doi: 10.1007/BF02944353.

Abstract

Despite the fundamental importance of reporting of suspected adverse drug reactions, less than 10 per cent of serious adverse drug reactions are reported. To further enhance our understanding of doctors' knowledge and attitudes to the current Adverse Drug Reaction (ADR) reporting scheme we surveyed 158 doctors, including some 106 general practitioners and 23 hospital-based doctors. The response rate was 39.5 per cent. The majority had experience of reporting an ADR. Seriousness of the ADR appears to be the most important reason for reporting. Uncertainty that the adverse drug reaction was definitely caused by the medicine, that the adverse drug reaction was too trivial to report or that it was too well known a reaction to report are common reasons for not reporting. Of concern 84 per cent of doctors are unaware of the criteria of the National Drug Regulatory Agency indicating the need for additional education and information in this regard. We also found considerable disagreements in doctors' understanding of the meaning of common, occasional, rare, or very rare as applied to ADRs.

摘要

尽管报告疑似药物不良反应至关重要,但严重药物不良反应的报告率却不到10%。为了进一步加深我们对医生关于当前药物不良反应(ADR)报告制度的知识和态度的理解,我们对158名医生进行了调查,其中包括约106名全科医生和23名医院医生。回复率为39.5%。大多数人有报告ADR的经验。ADR的严重性似乎是报告的最重要原因。认为药物不良反应肯定由药物引起存在不确定性、药物不良反应太轻微不值得报告或该反应太常见无需报告,是不报告的常见原因。令人担忧的是,84%的医生不了解国家药品监管机构的标准,这表明在这方面需要更多的教育和信息。我们还发现,医生们对适用于ADR的常见、偶发、罕见或非常罕见的含义理解存在很大分歧。

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