藥物不良反應(yīng)之評估與通報(bào)作-展示頁
2025-06-06 01:59本頁面
【正文】 cisapride 1993Mar 2022 與某些藥物或具有危險因子之病人產(chǎn)生心率不整 cerivastatin 1997Aug 2022 31例死於橫紋肌溶解 國泰醫(yī)院藥物不良反應(yīng)工作小組組織 執(zhí)行祕書心臟內(nèi)科腎臟科胃腸科皮膚科神經(jīng)內(nèi)科感染科小兒科血液科過敏免疫 科急診醫(yī)科 學(xué)護(hù)理部社服室藥劑科副主席主席藥物不良反應(yīng)工作小組任務(wù) 1. 建立院內(nèi)藥物不良反應(yīng)通報(bào)原則及流程 2. 持續(xù)監(jiān)測、評估、確認(rèn)藥物相關(guān)之不良反應(yīng) 3. 提出建議通報(bào)之案例，呈請藥事委員會主委裁決 4. 嚴(yán)重需快速通報(bào)之案例，由藥劑科主任向藥事委員會 主委報(bào)告後直接通報(bào)，並於最近一次會議中報(bào)告追認(rèn) 5. 對醫(yī)療人員進(jìn)行宣導(dǎo)、教育、以提高病患的照顧品質(zhì) 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(zhí)行藥物不良反應(yīng)通報(bào)之流程 醫(yī)師 、 藥師 、 護(hù)理人員辨識出 ADR 填寫院內(nèi) 「 疑似藥物不良反應(yīng)通報(bào)卡」 藥劑科 病歷室 其他單位 資料之收集、評估 、 整理 確認(rèn)因果關(guān)係 會診各相關(guān)科意見 藥物不良反應(yīng)工作小組開會 是 填寫衛(wèi)生署藥物不良反應(yīng)通報(bào)表 決議是否需要通報(bào) ADR通報(bào)中心 教育 、 預(yù)防 (將案例分類整理 ?形成 資訊 ?變成預(yù)防方法 ) 衛(wèi)生署北區(qū) ADR通報(bào)中心 疑似藥物不良反應(yīng)通報(bào)卡 病歷號碼 : 通報(bào)日期 : 病床號 /診間 : 通報(bào)者姓名 : 科 別 : 通報(bào)者身份 :□ 醫(yī)師 □藥師 □護(hù)理人員 □病歷室 □民眾 □其他單位 懷疑之藥物名稱 起始日期 發(fā)生日期 目前之處理方式 請描述發(fā)生之不良反應(yīng) : progress note 是否有記錄 :□ 有 □無 *請資料填妥後 ,電話連絡(luò) ADR工作小組 分機(jī) : 3815； 3816 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 Healthsystem Pharmacists） : Any unexpected, unintended, undesired, or excessive response to a drug that 1. Requires discontinuing the drug（ therapeutic or diagnostic） 2. Requires changing the drug therapy 3. Requires modifying the dose 4. Necessitates admission to a hospital 5. Prolongs stay in a health care facility 6. Necessitates supportive treatment 7. Significant plicates diagnosis 8. Negatively affects prognosis, or 9. 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 dosedependent and predictable, but can be due to conitant disease states, drugdrug interactions , or fooddrug interactions ? ways to minimize such reactions: monitoring drugs with a narrow therapeutic window。 carcinogenic/teratogenic reactions ? seem to be a function of patient susceptibility ? Rarely predictable ? usually not dosedependent ? seem to concentrate in certain body systems such as liver, blood, skin, kidney, nervous system, and others ? unmon, generally very serious, can be lifethreatening Type B reactions ? 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 immunologic hypersensitivity, occurring as the results of unusual sensitivity to a drug ? idiosyncratic reaction: abnormal su
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