查詢結果分析
來源資料
頁籤選單縮合
題 名 | 藥品品質監視回收之現況與展望=The Current Status and Future Prospect for the Post-Marketing Pharmaceutical Products Quality Surveillance and Recalling |
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作 者 | 楊博文; 陳可欣; 戴雪詠; 劉麗玲; | 書刊名 | 食品藥物研究年報 |
卷 期 | 5 2014.12[民103.12] |
頁 次 | 頁380-386 |
分類號 | 412.24 |
關鍵詞 | 藥品回收; 藥品品質監測; Drug recall; Post-marketing pharmaceutical products quality surveillance; |
語 文 | 中文(Chinese) |
中文摘要 | 藥品上市後品質監測及回收作業,是確保民眾用藥品質及安全之重要管理機 制,包括藥品不良品通報系統及廠商主動通報等被動監視機制,並藉由政府端之市 售藥品品質監測、國外藥品品質警訊監控及製造廠稽查等主動監控,即時偵測藥品 品質異常訊號,立即調查及處理,必要時啟動藥品回收作業,以確保民眾用藥品 質。我國並於101年精進藥品回收管理規範,且已符合國際醫藥品稽查協約組織規 範。本研究針對102年度藥品品質監視回收案件進行探討,共計72件回收案件,其中 被動監視之回收案件(38件)與主動監控之回收案件數(34件)相當,顯示醫療機構、藥 局及廠商端之通報機制,與政府端之主動監控同屬重要。而被動監視之回收案件類 型主要為口服製劑疑似藥品本身出現變質情形(9件)或檢驗結果未符合規格(6件),亦 發現有5件為含類固醇成分外用製劑藥品發生含量測定未符合規格之情形。未來將強 化被動監視與主動監控之聯結,並持續精進藥品回收管理。 |
英文摘要 | Post-marketing pharmaceutical products quality surveillance and recalling is designed for the assurance of the drug safety and quality control for the general public. For example, passive surveillance system includes drug defects reporting system and manufacturer obligatory reporting system; active surveillance system comprises quality surveillance, alert monitoring and manufacture site inspection by government. These systems can effectively provide unusual signal detection which will allow government to promptly perform an inspection and take any needed actions. The drug recalling regulations were improved in 2012, and currently are in compliance with the PIC/S regulations. This research involves discussion related to the recalled pharmaceutical products from quality surveillance system back in 2013. In total of 72 recalled cases, 38 cases are from passive surveillance system and 34 cases are from active surveillance. These data highlight the importance of reporting system, while the passive surveillance is equivalent to the active surveillance. In those recalling cases of passive surveillance, 9 cases of the oral medication are deterioration, 6 cases of the oral medication and 5 cases of the steroid-contained topical medication are not compliance with the specification. In the near future, the integration of passive surveillance system and active surveillance system will be reinforced and the drug recalling regulations will be improved progressively. |
本系統中英文摘要資訊取自各篇刊載內容。