目的： 統整自發性藥物不良反應之資料，配合施行政策宣導及建立預防機制，為病人用藥安全把關。
方法： 從2007 年1 月至2011 年12 月共5 年期間於某一區域教學醫院藥物不良反應通報系統，收入之個案係符合通報條件，經由Anatomical Therapeutic Chemical code (ATC code ) 轉碼後，以描述性統計方法分析處理。
結果： 5 年期間共有3,916 人次之通報案件，其年齡中位數 (Interquartile range, IQR) 為62 歲 (50 ~ 74)，老人族群是孩童的23 倍，整體分析以臨床醫師通報比例最高 (57.71%)，通報藥物依據藥理學分析則以心血管藥物32.95% 最常見，抗感染製劑為24.55%、中樞神經用藥為19.42%，不良反應症狀分析以皮膚方面之臨床表徵的表現最多占36.54%，神經方面為13.31% 次之、最常通報藥物為ketorolac，最常通報前30 種成份藥物為全部案例44.55%，嚴重個案有2.6% (102 件) 通報至全國藥物不良反應通報中心。
結論： 為了病人安全及預防不良反應之發生，醫療人員應建立可供記錄、提示及處理之資訊系統，藉由系統之協助減少人為疏失，達到用藥安全之目標。
Objective: The data of adverse drug reactions (ADRs) were collected and analyzled for the purposes of patient safety on medication, policy advocacy and establishment of preventative mechanisms.
Methods: From the data of an electronic ADR reporting system, all the reports from January 2007 to December 2011 were included. Drugs were translated to Anatomical Therapeutic Chemical (ATC) codes. We retrospectively reviewed the ADR report and analyzed the results by using descriptive statistics.
Results: The total number of reports was 3916 over the 5-year period. The median (interquartile range,IQR) age of the patients was 62 (50 ~ 74). Reports related to the population of elderly patients > 65 years were 23-fold more frequent than those reported for children < 18 years of age. 57.71% of the ADR reporters were physicians. ADRs were most frequently related to cardiovascular drugs (32.95%), followed by anti-infection agents (24.55%), and central nervous system drugs (19.42%). The main clinical manifestation of system organ damage reported was damage to the skin and subcutaneous tissue disorder (36.54%), followed by nervous system disorder (13.31%).The most often reported medication was ketorolac. Approximately 44.45% of all cases involved the top 30 medications of most frequently reported ADRs. The seriousness of the ADR report (2.6%, 102) was assessed by the National Pharmacovigilance Center.
Conclusions: To prevent and decrease any undeserved drug reaction, medical personnel have built up systems for recording, monitoring, alerting and managing allergenic medications. This also has positive impact on patient care for medication safety.
