药物相关问题与药物警戒

这类反应由以下因素引起： 按已批准上市药品说明书
An adverse reaction is a response to a medicinal product which is noxious and unintended. This includes
规定的使用; 超过批准上市药品说明书
规定的使用，包括超量、
2
药物流行病学与药物警戒
Pharmacoepidemiology & Pharmacovigilance
药物流行病学( PE )：应用流行病学的知识、方法和理论研 究药物在大范围人群中的效应(疗效和不良反应)及其利用的 科学---认识药品在真实世界的临床有效性、安全性及价值
药物警戒( PV )：药物流行病学的分支学科，专注研究上市 药品在大范围人群中使用中的药品不良事件(ADEs) 或药品 不良反应 (ADRs) “Pharmacovigilance is a branch of pharmacoepidemiology but is restricted to the study, on an epidemiological scale, of drug events or ADRs.”
发现、评估、认识和防范 WHO defines
pharmacovigilance
药物的不良作用或任何其他 as the science
药物相关问题的科学和实践 and activities relating to
the detection, assessment,
活动
understanding and
UR 65 April 2014 www.who-umc.org 6
欧盟药物警戒规范
Guideline on good pharmacovigilance practices (GVP) –
Module VI EMA/873138/2011
VI.A.2.定义
VI.A.2. Definitions
adverse reactions which arise from: the use of a medicinal product within
the terms of the marketing authorisation; the use outside the terms of the marke-
UR 65 April 2014
不合理、不当用药所致伤害， www.who-umc.org
即临床用药错误
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乌普萨拉(Uppsala)报告
药物警戒 范围的扩展
WHO鼓励和支持所有成员国参入国 际药物监测计划，收集并交流由药品所 致不良反应，包括药品质量低下及不当 用药所致反应，并向WHO ADR数据库 报告
----《药物警戒的重要性》
prevention of adverse effects or any other
ห้องสมุดไป่ตู้
drug-related problem (DRP).
4
WHO News: An integrated,
global approach
Expanding and broadening
From《Pharmacovigilance》Edited by R.D.Manna & E.B.Andrews , 2002 John Wiley &Sons, Ltd
3
药物警戒(pharmacovigilance)
WHO定义(2002)：
WHO：“The Importance of Pharmacovigilance, 2002”
WHO News: An integrated, Global approach
Expanding and broadening pharmacovigilance
WHO encourages and supports all Member States participating in the WHO Programme for International Drug Monitoring to collate and communicate all adverse reactions due to medicinal products, including those due to inferior quality and Inappropriate use, to the WHO global adverse drug reactions (ADR) database.
乌普萨拉(Uppsala)报告
pharmacovigilance Since the 2002 WHO definition of
the term pharmacovigilance,
药物警戒 范围的扩展
its scope has expanded into three broad categories: Harm caused by the inherent
2014年药物流行病学学术年会
药物相关问题与药物警戒
曾繁典
华中科技大学同济医学院 2014. 10. 8 (西安)
1
提纲
药物流行病学及药物警戒的定义 药物警戒定义及其概念扩展 药物相关问题(DRP)的定义和类型 DRP与药学服务(PC)实践 临床常见ADR类型 药品治疗无效 不合理用药及用药错误 假劣药品是药物警戒高度关注问题 药物依赖性及成瘾性 合理用药与用药安全系临床PC的核心价值
VI.A.2.1. 不良反应
The definitions provided in Article 1 of
不良反应是指对药品产生的
Directive 2001/83/EC shall be applied for the purpose of this Module
有害的、且非所期望的反应。 VI.A.2.1. Adverse reaction
properties of the active substance
Harm caused by products of
inferior quality
Harm caused by inappropriate
药物固有属性所致伤害 假药、劣药所致伤害事件
use e.g.medication errors.