药物不良反应之评估与通报作.ppt

藥物不良反應之評估與通報作業 國泰綜合醫院 林惜燕 91.11.17 藥物不良反應之評估與通報 各國之藥物不良反應通報系統 執行藥物不良反應評估與通報之標準作業規範（SOP） 實例解說 資料分析 通報率之研究 未來發展 各國ADR通報系統 英國：Yellow-card system（Committee on Safety of Medicines） PEM（prescription event monitoring） 美國： FDA MedWatch 歐洲： EMEA（European Medicines Evaluation Agency） 世界性： WHO collaborating Center for International Drug Monitoring (The Uppsala Monitoring Center) UMC 我國於87年7月成立全國藥物不良反應通報中心，並於北、中、南、東區各設區域級通報中心 為何需要通報 為何需要通報 國泰醫院藥物不良反應工作小組組織 藥物不良反應工作小組任務 1.??? 建立院內藥物不良反應通報原則及流程 2.??? 持續監測、評估、確認藥物相關之不良反應 3.??? 提出建議通報之案例，呈請藥事委員會主委裁決 4.????嚴重需快速通報之案例，由藥劑科主任向藥事委員會 主委報告後直接通報，並於最近一次會議中報告追認 5.??? 對醫療人員進行宣導、教育、以提高病患的照顧品質 會議： 1. 每二個月召開一次會議 2. 必要時，主席可提請召開臨時會議 ADR之定義 WHO: any response to a drug which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function. FDA : 1. an adverse event occurring in the course of the use of a drug product in the professional practice 2 . an adverse event occurring from drug overdose, whether accidental or intentional 3. from drug abuse 4. from drug withdrawal 5. any significant failure of expected pharmacological action ADR之定義 ASHP（American Society of Health-system Pharmacists）: Any unexpected, unintended, undesired, or excessive response to a drug that Requires discontinuing the drug（therapeutic or diagnostic） Requires changing the drug therapy Requires modifying the dose Necessitates admission to a hospital Prolongs stay in a health care facility Necessitates supportive treatment Significant complicates diagnosis Negatively affects prognosis, or Results in temporary or permanent harm, disability, or death Type A reactions Extensions of the drug’s known pharmacology ; responsible for the majority of ADRs usually dose-dependent and predictable, but can be due to concomitant disease states, drug-drug interactions , or food-drug interactions ways to minimi