對藥品進行上市後的安全性監視並提供使用上的指引是美國食品藥物管理署(U.S. Food and Drug Administration, FDA) 重要的職責，2016 年2 月官方正式成立Sentinel System 作為藥品上市後的主動監視系統，相關的研究專家可以建立研究主題，並透過下拉式選單選取預先定義、參數化、可重複使用的分析方法，將完整計畫書提交至Sentinel 的平臺，最後再統整來自各個回傳的結果，提升取得研究結果的效率。Sentinel System 最主要的價值在於研究藥品在「真實世界」中的使用情形及安全性，特別是用來監測一些在隨機分派臨床試驗中沒辦法被發現的副作用。雖然，目前Sentinel System 尚未達到完全成熟的階段，但此系統確實能夠協助FDA 盡可能做出最佳的管理決策，並達到提升保障公眾健康安全的目標。未來臺灣能夠參考Sentinel System 的經驗，以目前的健保資料庫為基礎，再透過系統將資料庫與分析方法串聯，建立藥品主動監視平臺。
ince post-marketing surveillance and providing guidance on drugs are critical parts of U.S. Food and Drug Administration (FDA)’s duties, the Sentinel System was officially launched in 2016. Authorized users can establish a research question and choose an analysis method, which is pre-defined, parameterized, re-usable, through the drop-down menus. After query the Sentinel distributed database, they can retrieve results from each data partners. The main value of the Sentinel System is to know the utilization and safety of drugs in “real-world”, especially useful for monitoring adverse effects that might not be found in randomized clinical trials. Although the Sentinel System is not yet fully mature currently, the system plays a role in helping the FDA make the best possible decisions to reach the goal of promoting public health. We can learn from Sentinel System and connect current database with analysis tools to develop active surveillance plate-form in Taiwan.
