社團法人臺灣臨床藥學會

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【原著】某醫藥大學附設醫院藥物不良反應 通報系統執行概況
Adverse Drug Reaction Reporting System in a University Hospital
藥物不良反應通報、藥物安全監視制度、主動通報、adverse drug reaction reporting system, pharmacovigilance, spontaneous reporting
姚淑惠Su-Hei Yao1,4 、陳惠琍Hui-Lee Chen1 、賴琬姿Wan-Tzu Lai1 、吳錫金Hsi-Chin Wu2,5 、林正介Cheng-Chieh Lin3 、蔡輝彥Huei-Yann Tasi*1,6
1中國醫藥大學附設醫院藥劑部 、2中國醫藥大學附設醫院泌尿部 、3中國醫藥大學附設醫院家庭醫學科 、4中國醫藥大學藥學系 、5中國醫藥大學醫學系 、6醫學系藥理學科暨醫學研究所
    藥物安全監視制度的發展已有一百五十年的歷史,衛生署自1998年七月成立全國藥物不良反應通報系統,這是以收集藥品使用安全性資料為目的機制;中國醫藥大學附設醫院重視就醫病患用藥安全,早在衛生署通報系統設置前就成立隸屬於藥事委員會的藥物不良反應工作小組。有五項工作職責,一、評估藥物不良反應通報案件,二、制訂藥物不良反應控管機制,三、院內用藥安全宣導,四、通報案例統計分析、檢討與改進,五、發放通報者獎勵金。藥物不良反應通報案例審查確立者,控管工作包括病歷封面登錄不良反應藥物及發生型態、電子病歷註記欄位登錄、通知主治醫師該案例之評估結果,及填寫「病患藥物過敏記錄卡」給病患以防範病人再度用藥。從1998年至2004年共收集349件通報案例,先排除可疑及無法評估案例,有245名病患出現253個不良反應事件;病患年齡在70歲以上佔28.2%最高;通報的可疑藥品有292個品項,分屬129種藥物成份;藥理作用分類前三名分別是中樞神經作用藥、抗感染藥及心臟血管暨腎臟用藥;不良反應發生型態以皮膚病變居首位,其次為心臟血管及中樞神經性反應。僅16.3%案例有記載藥物過敏史;因此,本院自2005年起規定醫師處方前需確認病患之藥物過敏史且電腦登錄為病患用藥安全把關。

Developing an ideal Pharmacovigilance system has been endeavoring for 150 years. Taiwan’s national reporting system of adverse drug reactions (ADRs) aiming to collect drug safety information nationwide was inaugurated in July 1998. However, early to that, the China medical University Hospital (CMUH) had established its own ADRs reporting system.
Under supervision of the hospital’s pharmaceutical and therapeutic (P&T) committee, five responsibilities were delegated to a working group which included: 1. evaluation of all spontaneous reported ADR cases, 2.establish an intranet-based system for delivery of reporting, monitoring and preventing information, 3.design educational programs for all related medical personnel, 4.data analysis of all reported events and make proper reactions to improve any untoward situation, 5.Awards the ADR reporters.
From Apr. 1998 to Dec. 2004, a total of 349 ADR events were reported. Excluding cases not available for further analysis, there were 253 ADR events occurred on 245 patients. About 28% of them were older than 70-years-old. Totally, two-hundred-and-ninety-two drugs as belonging to 129 pharmacological constituents were found to be related to the reported ADR events, among them, drugs used for central nervous system, infection and cardiovascular-renal systems are most common. Skin reactions were the most common clinical manifestations reported for ADRs, following with the symptoms and signs for cardiovascular and central nervous systems. However, of the 245 patients suffered from ADR events, only 16.3% had had their drug allergy histories well documented on medical records. We therefore implemented a policy commanding that before any drug prescription can be activated the prescribing doctor must fill in a column for patient’s drug allergy history on the intranet automated reporting system. This policy has proved to be an effective measure in reducingADR events ever since its inauguration in Jan. 2005.
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