頁籤選單縮合
題 名 | 某醫學中心藥物不良品通報系統執行分析及探討=Implementation of Medical Defect Products Reporting System in a Medical Center |
---|---|
作 者 | 陳怡瑾; 吳秋瑩; 戴慶玲; 李炳鈺; | 書刊名 | 藥學雜誌 |
卷 期 | 27:4=109 2011.12[民100.12] |
頁 次 | 頁121-126 |
分類號 | 412.24 |
關鍵詞 | 藥物不良品通報; 藥物安全監視; 通報流程; Medical product defect Reporting system; Drug safety surveillance; Notification procedures; |
語 文 | 中文(Chinese) |
中文摘要 | 自從衛生署執行藥物回收暨通報機制以來,凡是發現違反藥事法所規定之偽藥、禁藥、劣藥、及不良醫材等情形,或有疑似因藥物不良品而可能導致病人受到傷害時,皆可通報藥物不良品系統,藉由全國性通報系統的設置,全民共同監督,讓廠商得以檢討改進,達到全面品質提升,這也是了解藥品上市後品質資訊的重要方式,但是現今醫療人員工作負荷量龐大,持續使用過去紙本的通報方式,無法即時將不良品狀況反應至中央主管機關並獲得有效的處理,由於使用藥物不良品可能會危害病人,導致不良反應發生,本院重視病人用藥的安全,為便利院內同仁通報,自民國98年3月開始建置電子化通報系統,讓藥物不良品相關資料蒐集,得以更加迅速完善。 |
英文摘要 | Since drugs recall and notification system have been implemented by department of health, those violating the pharmaceutical affairs act like counterfeit, prohibited and illegal medicines and any medical devices which may be hazardous to the consumers or users, can be reported via the medical defect products reporting system. When the defect medical products are detected, health care providers, manufacturers, and the public are encouraged to report the cases to national reporting center through mail, fax, email, or the on-line reporting system. By means of setting up the national medical product defect reporting system in Taiwan, we could prevent people from being harmed due to defect medical products and ensure the quality of medicines. However, due to the huge burden of workload, it seemed not efficient to pass the message to the national medical product defect reporting system by the traditional way. We care about the medication security of patients and thus we have implemented numerous pharmacovigilance activities in recent years to encourage health care professionals to report defect medical products through on-line reporting system since March 1999 in our hospital. By this way we can collect data more rapidly and completely, hence to promote public health. |
本系統中英文摘要資訊取自各篇刊載內容。