建立中藥使用風險管理機制之研究

陳鴻儀
中國醫藥大學
隨著中藥臨床應用日趨普及，其安全性和可能引起的毒性逐漸被關注。可能會引起的毒性，例如減肥藥、壯陽藥以及一些治療指數小的中藥（例如：烏頭屬、馬兜鈴屬、等）。很多中藥不良反應報導，常常都是因為中藥的錯誤使用所造成。因此，中藥的藥物流行病學調查研究和藥物的主動監視，提供有效的臨床使用中藥安全資訊。
由於中藥的藥理活性成份複雜，處方藥材變化大，加上炮製方法各異。電腦化的臨床決策支援系統，逐漸被醫療專業人員應用作為下決策的基礎。這樣的電腦化臨床決策支援系統可以作為藥師針對醫師處方的評估以及病人治療成效的評估，特別是對於安全警訊方面的藥物交互作用、禁忌症以及劑量監測和調整。
希望藉由中國醫藥大學附設醫院執行中醫藥相關業務的豐富經驗，以其嚴謹的中藥局管理制度為藍本，加上訪視調查研究國內各醫院中藥局調劑現況。將病患的藥品調劑、煎煮、給藥、藥物諮詢、高警訊中藥管理、中藥臨床藥事服務等，加以歸納整理，建立以病人為中心的「制度化與規格化的給藥服務」、「提供藥品資訊」、「個人化藥物諮詢服務」、與「提升病患用藥安全」四個層面，使中醫臨床藥事照護制度更為完整和安全。我們期望透過本計畫，建立對中醫門診病患提供中藥安全有效的藥事照護模式，減少病人使用中藥嚴重不良反應！確保病人使用中藥安全無虞，提高治療效果，發揮藥師中藥臨床服務的功能。
所以，本研究計畫著手於中醫門診藥事給藥作業及環境安全評估機制以及中藥使用安全流行病學調查。
關鍵字：中藥， 藥事照護，風險管理

Mechanism of risk management in traditional Chinese medicines

Hung-Yi Chen
China Medical University
With the growing popularity of Traditional Chinese medicines (TCM) in clinical uses, their safety and toxicity may be gradually concerned about. Those may cause toxicity, such as weight control pills, impotence drugs, and some small therapeutic index of TCM (for example: Aconitum genus, Aristolochia, etc.). Many adverse effects of TCM are reported, often because of errors caused by the use of TCM. Therefore, the TCM research and pharmacoepidemiology of active surveillance provide effective safety information. 
TCM have complex pharmacological ingredients, prescriptions coupled with different processing methods. Computerized clinical support system was gradually applied by medical professionals as the decision-making of prescriptions. This computerized clinical decision support system is available for the assessment of prescriptions by pharmacists , especially in regard to drug interactions, contraindications, and dose monitoring and adjustment. 
With the implementation of China Medical University Hospital related TCM best business experiences, we survey the hospital status of TCM dispensing in Taiwan. The TCM dispensing, counseling, management of high alert medicine, clinical pharmacy services are to be collated and analyzed the establishment of patient-centered institutionalized, standardized delivery service, provides drug information and to enhance patient medication safety. So clinical pharmacy care system of TCM will become more complete and safe. With the support of this grant, we hope to provide patients with safe and effective TCM pharmaceutical care model, and to reduce serious adverse reactions. 
Therefore, our study will focus on the outpatients outpatient pharmaceutical services and assessment of risk management at environmental safety and pharmacoepidemiology of TCM.
關鍵字：Traditional Chinese Medicine, Pharmaceutical Care,Risk Management