药物不良反应与用药安全.ppt

藥物不良反應與用藥安全,台北醫學大學附設醫院藥劑部 林毓瑩, Pharm.D. Nov. 8, 2005,一些發生在北醫的例子,Case I.疑似Methotrexate過量引起之leucopenia,MTX overdose,不良反應之描述: 60 yo female patient was diagnosis with psoriasis in November,2004 and was given MTX (methotrexate) 2.5mg 3# 2 times a week from 11/5/2004 12/3/2004.,MTX overdose (cont),On 1/4/2005, pt was given high dose of MTX 2.5mg 3# 2 times “a day”(instead of 2 times a week) for 14 days. (1/4/2005-1/17/2005) She was given MTX 2.5 mg 3# bid again from 1/18/2005 for 28 days.,MTX overdose (cont),Then she did not come to the hospital until 8/30/2005. On 8/30, she was given MTX 2.5mg 3# bid again for 14 days.( 8/30-9/13),MTX overdose (cont),On 9/13 at OPD, she complained of chills/dizziness/SOB and oral ulceration. From the lab data, WBC: 2.13 (4-11), RBC: 3.68 (4.2-6.1), Hb: 11.9 (12-18), Platelet: 84K (130k -400k ) .,MTX overdose (cont),MTX overdose was suspected and admission to the hospital was suggested. But pt didnt take suggestion and went home. Folina (leucovorin) 15mg 1# po q6h x 4 days was given.,MTX overdose (cont),On 9/16, pt went to the ER due to high fever (38.5C). Skin ulcer, leukopenia and unspecified septicemia was noticed. Lab data at ER: WBC: 2.0 ( 4-11), RBC: 3.87 (4.2-6.1), PLT: 164 (130-400),MTX overdose (cont),Med profile after admission (9/16-9/21): (1) Leucovorin 15mg po q6h (9/16-9/21) for MTX overdose (2) Mycostatin oral rinse tid (9/16-9/21) for oral ulcer (3) GCSF (Filgrastim) inj. qd (9/16-9/21) for leucopenia (4) Dexaltin oint. tid (9/16-9/21) for skin care (5) Bacitracin-Neomycin oint. bid (9/16-9/21) for trunk ulcer (6) Tinten 500mg q6h prn (9/16-9/19) for fever,MTX overdose (cont), Lab data on 9/18/2005: - WBC: 7.32 (4-11) - RBC: 3.14 (4.2-6.1) - PLT: 282 (130-400) Pt was discharged on 9/21/2005.,Case II.疑似amiodarone引起之hypothyroidism,Amiodarone-induced hypothyroidism,不良反應之描述 53 yo female pt was on amiodarone 100mg po qd since 91/03/07. On 93/06/17, abnormal thyroid function level was noticed: TSH: 8.37 (0.4-5.0) T3: 101 (75-195) T4: 9.9 (4.5-12.5),Amiodarone-induced hypothyroidism,Patient started to take Eltroxin 0.05mg po qd on 93/06/24, dosage was increased to 0.1mg po qd on 93/07/08, and increased again on 93/07/29 to 0.2mg po qd. But Amiodarone 100mg po qd was still on the medical profile. On 93/10/28, low level of TSH was noticed ;TSH 0.05 (0.4-5.0). Physician was informed. TSH=2.23(0.4-5.0) on 94/4/22.,Case III.疑似Fluconazole引起之Liver toxicity,Fluconazole-induced hepatotoxicity,不良反應之描述 27 yo male patient encountered car accident on 94/2/24 and was sent to the ER with DOA. After CPR and surgery, he was sent to the ICU for further observation.,Fluconazole-induced hepatotoxicity,On 94/3/23, fluconazole 100mg iv qd was given, and after 3 days, GOT/GPT was jumped from 55/45 to 633/410. Fluconazole was d/c immediately on 3/26, and GOT/GPT was returned to normal afterward.,藥物不良反應發生率及醫療花費,ADR 發生率及醫療花費,台灣某醫學中心住院病人發生ADR比率: 5% (report in 1992) Over 75% of all ADRs are dose related, occurring at standard, manufacturer-recommended doses. (Medscape Pharmacotherapy. 1999. ) A 700-bed teaching hospital spends US$5.6 million on ADR in a single year. (Bates D.,JAMA 1997),美國因醫藥疏失(ADR+ medication erros)死亡總數,“Patient Safety in American Hospitals”(Aug.,2004) Health Grades 針對全國50個州的Medicare 病人資料追蹤3年 (2000-2002),三千七百萬病人資料 (佔全國住院病人的 45%) 一百一十四萬病人 (3%) 在2000-2002年因住院而發生病患醫藥安全問題. 因醫藥疏失死亡總數: 195,000人/ 年,相當於約400台載滿乘客的 Boeing 747,藥物不良反應的定義、分類、嚴重度,Definition of ADR (adverse drug reaction),WHO 在預防、診斷、治療劑量下發生的有害或不欲有的反應。,Definition of ADR,美國藥物食品管理局(FDA) (1)在專業執業中，於使用藥品的過程所發生的不良反應 (2)意外或蓄意葯品劑量過高所造成的不良反應 (3) 因藥物濫用所照成的不良反應 (4) 因停藥所發生的不良反應 (5) 顯著的未達到預期藥理作用,ADR 之分類,可預期 (Type A) - 正常藥理反應之延伸,與劑量有關,通常極少違及生命 不可預期 (Type B) - 特異體質 (Idiosyncratic reaction) - 過敏反應 (Hypersensitivity reaction),ADR 嚴重度,輕微 (Minor) 無須解藥,治療,或延長住院時間 中等 (Moderate) 須改變用藥或予以特別治療 嚴重 (Serious) 死亡、危及生命、永久性傷害、導致住院、延長住院、須處置以防止永久傷害、須至加護病房、畸胎,2004年台灣ADR通報案例分析,台灣藥物不良反應通報情形,ADR 個案通報來源,2004年ADR通報案例分析,區域 個案數 百分比(%) 區 955 38.09 中區 599 23.89 南區 763 30.43 東區 190 7.58 Total: 2507 通報源 個案數 百分比(%) 藥師 1690 67.41 醫師 420 16.75 護士 141 5.62 其他醫人員 45 1.79 藥商 167 6.66 民眾 44 1.76,2004年ADR通報案例分析,個案齡 案件數 百分比(%) 80 199 7.94 MeanSD 49.1323.84,2004年ADR通報案例分析,不良反應結果 案件數 百分比(%) 死亡 61 2.43 危及生命 73 2.91 導致病人住院 310 12.37 造成永久性殘疾 5 0.20 延長病人住院時間 123 4.91 需作處置以防永久性傷害 527 21.02 先天性畸形 0 0.00 其他 1293 51.58 未填 115 4.59,2004年ADR通報案例分析,型態 案件數 百分比(%) A (可預期) 602 24.01 B (不可預期) 1719 68.57 知 186 7.42 嚴重 案件數 百分比(%) 輕 493 19.66 中 1364 54.41 重 252 10.05 無法評估 213 8.50 知 185 7.38 P.S.中度:改變用藥或予以特別治療,懷疑藥品之藥分,藥理分類 案件數 百分比(%) 經系統用藥 858 30.12 抗感染用藥 833 29.24 心血管用藥 303 10.64 抗腫瘤藥物 163 5.72 胃腸道用藥 98 3.44 免疫用藥 93 3.26 賀爾蒙藥物 89 3.12 診斷用藥 88 3.09 呼吸系統用藥 85 2.98,反應通報案懷疑藥品前十名及其常被通報之反應症,反應通報案懷疑藥品前十名及其常被通報之反應症,ADR 通報目前台灣的現況,1.缺乏鼓勵通報之機制 2.對通報保留態度,擔心洩密 3.認為所發生的ADR都是常見的、眾人皆知 4.不習慣思考藥物引起的問題，認為有問題就加藥 5.認為通報只為評鑑 6.通報作業繁瑣 7.工作繁忙沒時間 8.不知如何通報 9.不知需要通報,How ADR reporting improve pts care,藉案例收集、評估、分析 1.已知不良反應發生頻次 2.少見或未知的不良反應 3.採取措施(如警訊、用藥規範)，提升用藥安全 4. In addition ,1. Allergy Documentation: update the patients medical record/pharmacy profile. 2. Policy and Procedure Modifications : Medications with a high potential for ADEs should be strictly monitored by means of specific policies and procedures. 3. Educational Programs 4. Peripheral Brains: electronic order entry warning screens, labels,各國ADR通報系統及來源,各國ADR通報系統,美國: FDA MedWatch 英國: Yellow-card system, PEM (prescription event monitoring) 歐洲: EMEA (European Medicines Evaluation Agency) 世界性: WHO collaborating center for international drug monitoring 台灣: 全國藥物不良反應通報中心 (since July,1998),各國藥物不良反應通報來源,北醫不良反應通報流程,北醫與同儕醫院收案與通報數比較,北醫藥品/醫療器材不良反應通報流程,疑似 ADR 案例,藥劑部臨床藥學組,ADR 工作小組,藥事委員會,北區ADR 通報中心,1. Call 2113 2.網路線上通報 3.寫藥品不良 反應回報單,收集數據, 評估,審核案例