109年度藥害救濟審議案例分析   全文下載

Survey on Reviewed Applications of Drug Injury Relief in the Year 2020

「藥害」係指民眾依醫藥專業人員之指示或藥物標示使用藥物卻引起嚴重藥物不良反應。我國建立藥害救濟制度，並進行藥害救濟申請案之審議，使民眾產生藥害時無須經過長時間訴訟就能獲得及時救濟。本報告分析109年度經衛生福利部藥害救濟審議委員會完成審定之案例共186件，其中共121件申請案予以救濟，予以死亡、障礙及嚴重疾病給付分別為34件（28.1%）、7件（5.8%）及80件（66.1%），亦有65件申請案經審定不予救濟。受害人之平均年齡為53.3歲，其中申請死亡、障礙及嚴重疾病給付之案件數分別為56件（30.1%）、13件（7%）及108件（58.1%）。予以救濟之案件，藥物類別以全身性使用之抗生素占比最高（31%），藥害型態以皮膚及皮下組織疾患不良反應為大宗（60%以上），疑似藥物排名以rifampin/isoniazid/pyrazinamide（單方或複方）為最。食藥署將持續致力於藥害預防之宣導，以建立醫療專業人員及民眾用藥安全之觀念，並期待能達到預防藥害之目標。

Drug injury refers to serious adverse drug reaction caused by drugs which are taken according to the instructions of medical professionals or drug labeling. Taiwan has established drug injury relief system, and been reviewing drug injury relief applications to ensure that citizens can obtain timely relief without prolonged litigation when drug injury occurs. In this study, 186 cases were reviewed by the Drug Injury Relief Review Committee of the Ministry of Health and Welfare in the year 2020, of which 121 cases were approved for relief. Among them, the number of cases approved death, disable and severe illness payment were 34 (28.1%), 7 (5.8%) and 80 (66.1%) respectively. There were also 65 cases not approved for relief payment. Based on the basic data of the reviewed cases, the average age of the victims is 53.3 years old. Among them, the number of cases applying for death, disable and severe illness payment were 56 (30.1%), 13 (7%) and 108 (58.1%) respectively. Analyzing the statistics of cases approved for relief, systemic antibiotics accounted for the highest proportion of drug types (31%), and the most common type of drug injury is skin and subcutaneous tissue disorders (above 60%). Of the cases approved for relief, rifampin/isoniazid/pyrazinamide, including single prescription preparation and compound preparation, ranked the first suspected drug. To establish the concept of medication safety for medical professionals and the public, TFDA is committed to the advocacy of drug injury prevention, and expect to achieve the goal of drug injury prevention.