临床用药与医疗纠纷(1).pptVIP

dklee 药品说明书之外的用法－发生率 Oklahoma Children’s Memorial Hospital,250 beds, Feb 13-Mar 4 1985(19days), 951 drug orders: Unlabeled use 62(7%) Consensus of appropriate use 24(39%) Consensus of inappropriate use 10(16%) No Consensus (45%) Am J Hosp Pharm 44:792 1987 dklee 药品说明书之外的用法－发生率 JAMA 266(21):2996 1991 dklee 药品说明书之外的用法---案例PDR---环孢素A 说明书用法 说明书之外用法 1997年，第51版 预防肾、肝、心脏的同种移植后排斥反应 预防胰腺、骨髓、心－肺联合移植后排斥反应 银屑病 类风湿性关节炎 Crohn`s 病等 2003年，第57版 预防肾、肝、心脏的同种移植后排斥反应 类风湿性关节炎 银屑病 预防胰腺、骨髓、心－肺联合移植后的排斥反应 Crohn`s 病等 dklee MTX的适应症比较---PDR 1988年 第42版 1991年 第45版 恶性肿瘤 银屑病 恶性肿瘤 银屑病 类风湿性关节炎 dklee Unlabeled (Off-Label) Use其他案例 Aspirin：解热镇痛/风湿/抗血小板聚集 Furazolidone(痢特灵)：痢疾/消化道溃疡 砒霜/亚砷酸钠：毒药/白血病/其他癌症 dklee ALBUTEROLFDA LABELED USES ASTHMA BRONCHOSPASM - EXERCISE-INDUCED Micromedex 2004 Q1 dklee ASTHMA  FDA Labeled Indication 1. OVERVIEW: FDA APPROVAL: Adult, yes; pediatric, yes  EFFICACY: Adult, effective; pediatric, effective  DOCUMENTATION: Adult, good; pediatric, good  2. SUMMARY: - Albuterol, by inhalation, is indicated for the  prevention and relief of bronchospasm in patients  with asthma  - Concurrent use of inhaled steroids with inhaled  beta-agonists may decrease the risk of  hospitalization in patients with increased  beta-agonist use  Micromedex 2004 Q1 dklee ALBUTEROLTHERAPEUTIC USES ADENOVIRUS INFECTION ASTHMA ATOPIC DERMATITIS BRONCHIOLITIS BRONCHOSPASM - ANESTHESIA-INDUCED BRONCHOSPASM - EXERCISE-INDUCED BRONCHOSPASM - MECHANICAL VENTILATOR-INDUCED CARDIOGENIC SHOCK CHRONIC OBSTRUCTIVE PULMONARY DISEASE CONGESTIVE HEART FAILURE COUGH CYSTIC FIBROSIS Micromedex 2004 Q1 dklee DEPRESSION EMPHYSEMA EXERCISE PERFORMANCE FACIOSCAPULOHUMERAL DYSTROPHY GAMSTORPS SYNDROME HYPERKALEMIA PARKINSONS DISEASE PERTUSSIS PREMATURE LABOR RESPIRATORY DISTRESS SYNDROME OF PREMATURITY RESPIRATORY SYNCYTIAL VIRUS URINARY INCONTINENCE Micromedex 2004 Q1 dklee PREMATURE L