社團法人臺灣臨床藥學會

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【原著】某教學醫院藥物不良反應之通報與評估
Reporting and Evaluation of Adverse Drug Reactions in a Teaching Hospital
藥物不良反應、Naranjo algorithm、藥物不良反應型態、預防性指標、嚴重度指標、adverse drug reactions, Naranjo’s algorithm, type of adverse drug reactions, preventability, severity scale
王瑩玉Wang Ying-Yue 、劉惠文Liu Hui-Wen
1馬偕紀念醫院 藥劑室
衛生署於87年7月建立全國藥物不良反應(ADR)通報系統,民國89年為配合政策而列入醫院評鑑項目,加強查考各醫院在藥物不良反應作業的實施狀況,因此藥師熟悉藥物不良反應的評估是重要的。本院自90年12月至92年12月約二年期間,共收集93個自動通報且經藥物不良反應小組確立之案例,除了以Naranjo algorithm評估致因藥物與不良反應的相關性外,亦評估藥物不良反應的可預防性及嚴重度等面向。在93個案例中依Naranjo algorithm評為極有可能案例佔65.5%,依可預防性指標評為不可預防的案例佔61.5%。在藥物不良反應的嚴重度方面,依據文獻之嚴重度指標所得的結果與依衛生署的ADR表格所作的評估結果一致者只佔總案例之57%。本研究指出醫院藥師以不同面向評估藥物不良反應的積極作為。

Many countries established a spontaneous reporting system for monitoring adverse drug reactions (ADRs), such as MedWatch of FDA, which provides important and timely clinical information about safety issues of medical products.  The National Reporting Center of Adverse Drug Reactions, established by the Department of Health (D.O.H.) on July 1998, set up 4 regional reporting centers to collect relevant information.  This present study collected ADR reports from physicians, pharmacists, nurses, and patients in the Mackay Memorial Hospital over a period of 2 years (December 2001 – December 2003).  The causality, preventability and severity of ADRs were evaluated according to published criteria and the official ADR forms provided by D.O.H.  Overall, there were 93 identifiable adverse drug events: 65.5% of the cases were considered probable by Naranjo’s algorithm and 61.5% were not preventable based on the preventability scale of Schumock and Thornton.  As for severity of ADRs, 57% of the cases—when evaluated by a severity scale—matched the results by the official ADR forms. The present study demonstrated an active role of hospital pharmacists, in which the pharmacists review and evaluate different aspects of ADRs. 
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