林香汶 中國醫藥大學附設醫院
國人對中藥的觀念大多為中藥是純天然的、相較於西藥對人體較無害且不但可以有病治病沒病也可強身。然而，不當的使用或管理仍可能造成使用中藥後的毒性或不良反應的發生。不論是馬兜鈴酸的中藥材事件、誤用或不適當使用中藥所造成的風險，可能都會帶來社會及健保醫療資源額外的負擔。為確保中藥高風險藥品之用藥安全，並提升中藥從業人員承擔民眾使用高風險中藥風險責任，本計畫預計實施三階段。 (一)中藥評估及風險實證資料庫之建立: 利用結構性文獻搜尋的步驟，針對高風險中藥，利用國內外相關資料庫進行系統性的文獻搜集、回顧、評估及分類，其內容將包括中藥毒性分級、孕婦禁用藥物分類及重要服用中藥禁忌等，依成立之專案小組進行審查、討論及評估會議。 (二)中藥安全用藥使用評估暨風險管理之建立: 將先針對高風險中藥，進行全國性及機構內之藥物使用評估，找出常用的高風險中藥種類，進一步評估其建立機構內高風險中藥藥品安全使用暨風險評估、追蹤及管理機制。其目的是希望找出台灣實際發生的問題並找出解決之道。 (三)規劃與設立高警訊中藥仿單草案: 將依前兩階段研究成果找出高警訊中藥，針對最重要的高警訊中藥及或方劑規劃並設立其仿單內容，由專案小組召開會議，討論高警訊中藥仿單內容之適當性等。希望藉由本計畫之實施，可瞭解高風險中藥之全國性及機構內使用的具體面貌，以做為醫療人員及醫藥衛生政策決策者之參考；所建立之中藥安全用藥使用評估暨風險管理評估、追蹤及管理機制及高警訊中藥仿單草案可作為他院的參考，以期藉此以促進安全中藥使用知識的傳遞更進而促使高風險中藥安全使用的目的。
關鍵詞：中藥、用藥安全、用藥使用評估、風險管理
Drug utilization evaluation and risk management of safety medication use in Chinese Medicine
Hsiang-Wen Lin China Medical University Hospital For a long time, Chinese medicine (CM) related products are recognized as natural, safe and usually are good to strengthen body in Chinese society. However, it is unfortunately that CM products still might causes risks and undesired consequences, which would result in adding extra burden on society and National Health Insurance (NHI) coverage in Taiwan , once these CM products are managed or used inappropriately. To ensure safe medication use among the high risk CM products and enhance CM practitioners’ awareness and responsibility to minimize such risks, this research aims to complete the following three stages of study. First, we plan to develop a safe and evidence-based database about safe CM products through comprehensively literature review and expert panel discussions. Second, we will establish the draft of CM drug utilization evaluation and risk management model through conducting the data analysis and pharmacoepidemiology study using national and local medication use databases. The, we plan to facilitate in-depth discussions about safe use of CM products and its possible strategies to minimize the risks and its corresponding, appropriate management approaches. Last, we plan to develop the draft of package insert for the selected high risk CM products after compiling the findings from the first two stages of study. This is one of the studies to examine the safe medication use of high risk CM products in Taiwan. Ideally, it is expected to establish a stronger evidence-based database and summarize the research information to come up with a better model to monitor safe use of CM products and its risk management in Taiwan.
