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1、风险管理计划中的药物警戒内容Pharmacovigilance activities in context of RMPAgenda 目录Introduction简介Some Pharmacovigilance Activities beyond Routine with examples一些特殊药物警戒活动及说明Most common pharmacovigilance plan activities for Novartis RMPs 诺华产品常见的药物警戒活动 及举例| Pharmacovigilance activities | August 2010 | Risk Managemen
2、t Plan (RMP) | Business Use Only2Introduction 简介| Pharmacovigilance activities | August 2010 | Risk Management Plan (RMP) | Business Use Only3Product Safety is monitored through Pharmacovigilance 药品的安全是通过药物警戒活动来监测的Pharmacovigilance: Science relating to the detection, assessment, understanding and pr
3、evention of adverse effects of medicines药物警戒是一 门关于探测，评价，理解和预防药物药物副作用的科学Objectives目标: Identify and quantify previously unrecognized adverse drug reactions that are only evident with widespread or prolonged use对那些只有在广泛长时间应用才能显现的药物 不良反应进行识别并量化已经识别的信号 Identify patient sub- groups that may be at increase
4、d risk for reactions识别高风险的病人 亚群 Continued monitoring to ensure that risk- benefit balance remains acceptable持续进行监 测以保证风险效益的平衡 Detect inappropriate prescription and administration识别不当处方和药物应用Routine pharmacovigilance is the ongoing collection and monitoring of safety information postmarketing (AE repo
5、rts, Periodic Safety Update Reports) 常规的药物警戒活动是持续地收集，监测上市后的药物安全信息 （如不良事件报告， 定期安全性报告）4| Pharmacovigilance activities | August 2010 | Risk Management Plan (RMP) | Business Use OnlyPharmacovigilance ActivitiesFor most drugs, routine pharmacovigilance should be adequate 对于大多数药 物，常规的药物警戒活动是足够的Consider wh
6、en routine pharmacovigilance is likely to be inadequate, e.g.如下情 况时，可能需要考虑常规药物警戒以外的活动serious safety risks have been identified pre-or post- approval在上市前或上市 后发现了严重的安全性信号 at- risk populations have not been adequately studied 对风险人群没有足够的研 究数据potential risk with drug also has significant background occur
7、rence in target population, e.g. myocardial infarction in a drug for hypertension药物风险和治疗 人群本身具有的特定风险重合 比如某治疗高血压的药物的潜在风险是心梗，高 血压患者本身就有心梗的风险 Difficult to distinguish drug effect from “normal” incidence 难以辨别风险和药物的关系 Study with a control group receiving active comparator or placebo to facilitate accurat
8、e attribution of the AE could address this 利用对照组服用活性对照药或安慰剂 的研究有助于准确寻找不良事件的原因5| Pharmacovigilance activities | August 2010 | Risk Management Plan (RMP) | Business Use OnlySome Pharmacovigilance Activities beyond Routine一些特 殊药物警戒活动及说明| Pharmacovigilance activities | August 2010 | Risk Management Plan
9、 (RMP) | Business Use Only6Some Pharmacovigilance Activities beyond Routine一些特殊药物警戒活动1.对特定事件的额外分析，递交2.有针对性的主动监测研究 （针对某药物，某事件，某场合）3.药物流行病学研究（观察性）4.登记/注册研究5.患者或医生调研6.附加的基础实验或临床试验| Pharmacovigilance activities | August 2010 | Risk Management Plan (RMP) | Business Use Only7Examples of Pharmacovigilance
10、Activities beyond Routine 一些特殊药物警戒活动举例 （续）1. Additional analyses or more frequent intervals 重点分析 1.1 Additional listings/analyses or more frequent submission of adverse events of special interest 对特定不良事件提供额外的列表或分析，或提高递交的频率 1.2 Aggregate summaries at more frequent intervals than required 将常规的定期总结 报告提
11、高递交频率2 Active surveillance studies 主动监测研究 to identify AEs that may or may not be reported through passive surveillance 可以识别在被动监测的过程中没有报告的AE. Can be 可以是 2.1drug based: identifying AEs in patients taking certain products, 基于药物的基于药物的：从服用某些特定药物的的患者中识别AE 2.2 setting based: identifying AEs in certain heal
12、th care settings where they are likely to present for treatment (e.g., emergency dept), or 基于场合的基于场合的： 从某些患者可能因为治疗需要而出现的医疗 场合 （如急诊室）识别AE 2.3 event based: identifying AEs that are likely to be associated with medical products (e.g., acute liver failure) 基于事件的基于事件的：从相关医学事件中识别AE （比如：急性肝衰竭）3.Pharmaco- e
13、pidemiology studies(observational studies) 药物流行病学研究（观察 性研究） 3.1 Automated claims databases or other databases （利用医保数据库或其他数据库） 3.2 Cohort, case- control or other appropriate designs （队列，病例对照或其他设计）8| Pharmacovigilance activities | August 2010 | Risk Management Plan (RMP) | Business Use OnlyExamples of
14、 Pharmacovigilance Activities Beyond Routine 一些特殊药物警戒活动举例 （续）4.Registries登记An organized system for the collection, storage, retrieval, analysis, and dissemination of information on individual persons exposed to a specific medical intervention who have either a particular disease, a condition (e.g.,
15、a risk factor), or prior exposure. 一个有组织 的系统， 用来收集，储存，回溯，分析， 分发有关个体患者的信息， 个体患者因为患有 某种疾病或因为某种情况（比如某个危险因素），以前或正在应用某种特定的医疗干预 Whenever possible, a control or comparison group should be included, (i.e., individuals with a disease or risk factor who are not treated or are exposed to medical interventions
16、other than the intervention of interest).应该尽可能有对照组 （即那些没有被医疗干预/治 疗的患病或有危险因素的个人） Can be useful for:可用来- Collecting outcome information not available in large automated databases; and 收集 在大型医保数据库中没有的事件结果- Collecting information from multiple sources (e.g., physician records, hospital summaries, pathology reports, vital statistics), particularly when patients receive care from multiple providers over time. 收集各种来源的信息 （比如病历，住院小结，病理 报告，人口统计）特别是当患
