某區域教學醫院藥物不良反應通報現況

Reporting of Adverse Drug Reactions in a Regional Teaching Hospital

根據行政院衛生署所定義，藥物不良反應 （adverse drug reaction） 為基於證據、或是可能的因果關係，而判定在任何劑量下，使用藥品後所產生之有害的、非蓄意的個別反應。有感藥物不良反應通報系統對提昇全民用藥安全的重要性，自民國87年起，衛生署委託台灣臨床藥學會協助設置，此系統的運作業務範圍包括藥品及醫療器材之不良反應的通報作業及宣導，強化醫療人員對使用藥物引起之不良反應的認識，建立本土之藥物用藥安全資料庫，及通報資料之評估及資訊回饋制度，以達到合理用藥及提昇台灣民眾藥物使用安全性的設置宗旨。本院自88年起執行藥物不良反應通報，本文將說明藥物不良反應之定義、院內的評估過程以及近3年半以來的實施成果。在收集的483個通報案例中，經Naranjo評估表確認關聯性後，屬於極可能的案例最多，佔60.5%；發生部位以皮膚最為常見；依嚴重度區分則以輕度所佔比例最高，約87.2%，沒有任何重度或死亡的案例發生。

An adverse drug reaction (ADR) is defined as an appreciably harmful or unpleasant reaction, resulting from an intervention related to using a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, alteration of the dosage regimen, or withdrawal of the product. ADR is classified into Type A (dose-related) and Type B (bizarre reaction). Management includes withdrawal of the drug if possible and specific treatment of its effects. Suspected ADR should be reported. We collected 483 cases from the ADR reporting system in recent years. Overall, 60.5% were considered probable by Naranjo algorithm and skin reactions were the most reported events. As for severity, 87.2% were mild and there were no severe or fatal cases. We expect to share these data with other clinical physicians to better understand the prevalence and management of ADR.