药物安全与药物上市后监测-李青幻灯片.pptVIP

药物安全与药物上市后监测 李 青 介绍的内容 定义 药品不良反应的危害与认识 药品上市后监测的原因 国际上药品不良反应监测 我国药品不良反应监测 如何做好上市后药物监测 定义 Pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medicines, biological products, herbs and traditional medicines,with a view to : identifying new information about hazards,and preventing harm to patients. --- from Greek pharmakon-drug latin vigllare -to keep awake or alert, to keep watch Post-marketing surveillance = Phamacovigilance 定义 Adverse drug reaction（ADR） - A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for modification of physiological function International Drug Monitoring: The Role of National Ceentres. Geneva, World Health Organization, 1972 (WHO Technical Report, No 498). 药品不良反应: 主要是指合格药品在正常用法用量下出现的与用药目的无关的或意外的有害反应。 《药品不良反应监测及管理办法》(2003) 定义 Adverse event（药品不良事件） - Any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this treatment Side effect （副作用） - Any unintended effect of a pharmaceutical product occurring at doses normally used in man, which is related to the pharmacological proprieties of the drug  定义 Unexpected adverse drug reaction An adverse reaction, the nature or severity of which is not consistent with market authorisation, or expected from the characteristics of the drug. Predominant element is that the phenomenon is unknown. 非预期不良反应:指性质和严重程度与文献标志,或根据药物特性预料不到的不良反应. 定义 Serious adverse event?(严重不良事件) a. life-threatening or fatalb. cause or prolong hospital admissionc. cause persistent incapacity or disability; d. concern misuse or dependence ICH E6 guideline: substantially same as above plus: - congenital anomaly/birth defect 药品不良反应分