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1、藥物反應與用藥安全台醫學大學附設醫院藥劑部 林毓瑩, Pharm.D.Nov. 8, 2005一些發生在醫的子Case I.疑似Methotrexate過量引起之 leucopeniaMTX 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
2、 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
3、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 w
4、as 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
5、.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)
6、 Bacitracin-Neomycin oint. bid (9/16-9/21) for trunk ulcer(6) Tinten 500mg q6h prn (9/16-9/19) for feverMTX 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 hypothyroidismAmiodarone-induced hypoth
7、yroidism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 increase
8、d 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 80 199 7.94 MeanSD 49.1323.84 2004ADR通報案分析反應結果 案件 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
9、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 2004ADR通報案分析型態 案件 百分比(%)A (可預期)602 24.01 B (可預期) 1719 68.57 知 186 7.42 嚴重 案件 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:改變用藥或予以特別治懷疑藥品之藥分藥分 案件 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、 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 反應症懷疑藥品個主要症Vancomycin78Skin rash, itching, erythema multiform, red man syndrome, nephrotoxicity, renal dysfunction, fever, etc. Rifampin77Skin rash, jaudice, abnormal liver function, hepati
11、tis, nausea, vomiting, etc. Phenytoin71Skin rash, urticaria ,edema, allergy, etc.Diclofenac63Skin rash, urticaria, edema, etc.反應通報案懷疑藥品前十名及其常被通報之 反應症懷疑藥品個主要症Carbamazepine61Stevens Johnson Syndrome, skin rash, etc.Ketoprofen60Face edema, eye edema, skin rash, urticaria, allergy, etc Ketorolac53Allerg
12、y, urticaria, face edema, eyelid edema, diarrhea, rash, dyspnea, etc. Teicoplanin40Rash, face edema, fever, neutropenia, etc.Gemcitabine39Rash, fever, leukopenia, pneumonia, pain chest, etc Oxacillin36Rash, neutropenia, abnormal liver function, etc. 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,擔心洩密 3.認為所發生的AD
13、R都是常見的、眾人皆知 4.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.知如何通報 9.知需要通報How ADR reporting improve pts care藉案收集、評估、分析 1.已知反應發生頻次 2.少見或未知的反應 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 Modificat
14、ions : 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: 全國藥物反應通報中心 (since July,1998)各國藥物反應通報源CountryHealth ProfessionalsIndustriesConsumersU.S.A. 90%0%Australia67.22%29.19%3.59%
