某區域教學醫院藥物不良反應通報分析

Analysis of Adverse Drug Reaction Report of a Regional Teaching Hospital

配合衛生署推動「藥物不良反應通報」研究醫院於1999 年成立藥 物不良反應、工作小組，隸屬於藥事委員會，成員包括醫師、藥師、護理人員 及醫院管理高階人員。訂定藥物不良反應、通報炙手呈，確實掌握評估處理之時 效，以利藥物安全監視。通報方式可經由院內資訊象統及院內通報表兩種途 徑，小組成員會定期定時整理通報個案資料，並加以追蹤評估。藥劑科先針 對通報疑似個案資料彙整，進行初審，確立個案再提報藥物不良反應工作小 組委員複審，經複審確立個案就通報至藥物不良反應、通報中心。院內流程方 面，為確保用藥安全及防止再度發生同樣不良反應，於該患者病歷加註不良 反應、之型態與藥物，並立即告知主治醫師，且於每次藥事委員會議中將最近 一季藥物不良反應之統計結果列為常規報告。研究醫院通報個案資料從1999 年起至2003 年底止共收集115 件，排除可疑及無法評估者，有108 件確立通報 個案；通報者以藥師最多，其次為醫師及護理人員。依通報之可疑藥品排名 分析，前三名藥品為aspirin （101711） 、acemetacin （717~） 、diclofenac （6 例）依藥理分類分析，以非類固醇抗發炎藥物3 1. 4% 、抗微生物製劑14.8% 、中樞 神經系統抑制劑9.2%為前三名；依不良反應型態分析，以皮膚病變反應最常 見。女性與男性比例並無明顯差異，但通報個案年齡分佈以70 歲以上者（佔 25.9% ）最高。

The coordination of Department of Health, Executive Yuan, Taiwan, R. O. C. impetus National Reporting System of Adverse Drug Reactions (ADR) in Taiwan. Dajia Lee s General Hospital (DLGH) organized the ADR Work Team in 1999, subordinated to the Pharmacy & Therapeutics Committee (PTC), the members including doctor, pharmacist, nursing staff and the hospital management. We subscribed the ADR reporting program in order to help the pharmacovigilance and truly grasp effectiveness of reporting processing for a period of time. To report an ADR at DLGH, complete an ADR form (available on each nursing unit) and sent it to the pharmacy. An ADR can also be filed by e-mail or calling the Drug Information Center, if you have information about the patient, the reaction, the outcome, the suspected drug, and other relevant history. The panel members meet regularly, reorganize the reporting document, and perform to trace the report. The pharmacy first aimed at the suspicious reports to collect entirely and carried on the first examination. The suspected cases were further proposed to the ADR Work Team Committee to reexamine. Report significant or unexpected ADR s promptly to the Center of National Reporting System of ADR. For guarantee the drug safety and preventing the similar ADR occurs once again, we replenish the type of reaction and the medicine to this patient s medical record, and promptly inform the doctor in charge according to the monitoring program of DLGH. Additionally, the recent statistic results of ADR will be listed and as the conventional meeting report of the PTC in each time. One hundred and fifteen adverse drug reactions were voluntarily reported at DLGH from January 1999 to December 2003. A total 108 suspected cases were identified in this study. The initial reporters are most by the pharmacist, next for doctor and nursing staff. Aspirin (10 cases), acemetacin (7 cases), and diclofenac (6 cases) were the first three suspected drugs associated with drug-induced adverse reactions. The drugs most commonly involved were nonsteroidal anti-inflammatory drugs (NSAIDs, 31.4%), followed by antimicrobial agents (14.8%), and central nervous system (CNS) depressants (9.2%). Skin reactions are the most common type of reaction. There is no significant difference between female and male. However, 25.9% of ADR reports were found in patients older than 70 years of age.