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1、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 Ce
2、nter 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,行政院衛生署藥政處,表示ADR通報方向,表示藥品資訊傳方向,國內ADR個案通報流程 (來自各醫療人員、廠商及民眾),各區域級ADR通報中心(北、中、南、東),個案編碼及建檔,初步評估及篩選,全國ADR通報中心,召開專家會議（嚴重案例）,資料彙整,衛生署藥政處,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
3、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,執行藥物不良反應通報之流程,醫師、藥師、護理人員辨識出ADR,填寫院內疑似藥物不良反應通報卡,藥劑科,病歷室,其他單位,資料之收集、評估、整理,確認因果關係,會診各相關科意見,藥物不良反應工作小組開會,是,填寫衛生署藥物不良反應通報表,決議是否需要
4、通報,ADR通報中心,教育、預防,(將案例分類整理形成 資訊變成預防方法),衛生署北區ADR通報中心,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 occurr
5、ing 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 He
6、alth-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
7、 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 drugs known pharmacology ; responsible for the majority of ADRs usually dose-dependent and predictable
8、, but can be due to concomitant disease states, drug-drug interactions , or food-drug interactions ways to minimize such reactions: monitoring drugs with a narrow therapeutic window; avoiding polypharmacy when possible,Type B reactions,Idiosyncratic reactions, immunologic or allergic reactions; carc
9、inogenic/teratogenic reactions seem to be a function of patient susceptibility Rarely predictable usually not dose-dependent seem to concentrate in certain body systems such as liver, blood, skin, kidney, nervous system, and others uncommon, generally very serious, can be life-threatening,Type B rea
10、ctions,except for immediate hypersensitivity reactions, they usually take 5 days before the patient demonstrates hypersensitivity to a drug there is no maximum time for the occurrence of a reaction, but most occur within 12 weeks of therapy,Allergic vs idiosyncratic reaction,Allergic reaction: an im
11、munologic hypersensitivity, occurring as the results of unusual sensitivity to a drug idiosyncratic reaction: abnormal susceptibility to a drug that is peculiar to the individual,Case 1: Imipramine,15 month-old boy, suffered from cons disturbance frequent seizure-like movement Brain CT was performed
12、, mannitol IV was used under the impression of brain edema Cons disturbance was not improved Transferred to our ER, admitted to NCU Fell down from 30-40cm height chair 4 days ago ( no seizure, no cons disturbance, no vomiting or irritable crying ) EKG: QRS prolongation, QTc widening Imipramine level
13、: 1389g/l （therapeutic range: 150-250, toxic level: 500）,Case 2: acetaminophen,22 y/o lady, suffered from migraine since her childhood, it became worse 5-6 years ago, acetaminophen was given since then at LMD She stated that she took more than 10 tablets per day About one week ago, nausea, vomiting
14、and diarrhea attacked her for 1 day , then subsided But the condition became serious, she was send to ER GOT/GPT：6058/ 8732 HBS Ag, anti HBC-IgM, anti HCV, anti HAV-IgM：（-） Abdominal echo：fatty liver, hepatomegaly Concurrent medication：unknown,Case 3：metronidazole-peripheral neuropathy,50 y/o man ,
15、brain CT revealed brain abscess, treated with ceftriaxone, penicillin G, metronidazole Metronidazole 2g/d was stopped after a total of 43 days 15 days later, patient complained numbness of limbs, no headache , no nausea/ vomiting, no diplopia, no definite neurologic sign Numbness of the hands improv
16、ed 10 months later, but short-stocking like numbness of the feet persisted No other causes of peripheral neuropathy were found: alcoholism, amyloidosis, cancer, DM, heavy metal toxicity, hypothyroidism, malnutrition, medicines（amiodarone, cisplatin, ethambutol, hydralazine, isoniazid, nitrofuratoin, phenytoin,）,Ketoconazole hepatitis Case 4: 女性，36 歲，曾於 89 年 5月因急性肝炎入院，當時致病因子不明。患者於 90年 11 月再度因急性肝炎住院治療，排除病毒性肝炎之可能，
