CAJ | 학술논문

目的：明确“药品不良反应监测”的定义及范畴，厘清药品不良反应监测的概念。方法回顾“监测”的语源学，以及作为术语在疾病监测或公共卫生监测中的定义和范畴；回顾药品不良反应监测的历史与实践，以及信息技术发展对其的影响；分析“药品不良反应监测”、“药物警戒”与“药物流行病学”的概念框架。结果“监测”的目标是有危害可能的趋向。“持续”、“系统”、“收集”、“分析”、“解释”、“传播”是术语“监测”的基本元素。药品不良反应监测从药物获批上市即开始，收集的数据不仅涉及药物的性质，还涉及药品标准、药品生产、药品储存和药品使用。信息技术极大地推动了药品不良反应监测。结论建议定义药品不良反应监测为：一项以药品不良反应为目标的公共卫生项目，由一整套持续、系统性地收集、归整、分析和阐释药品对人体的危害方面的数据（包括相关的志愿报告、电子医疗记录和实验室记录等）并及时向所有应该知道的人（监管部门、医务人员或/和公众）反馈的过程组成。目的是认识药品安全问题的分布特征和变化趋势，鉴别、评价、认识和交流药品非预期的有害作用，进一步认识药品的获益-风险的属性，防范或使药品的有害作用最小化。
목적：명학“약품불량반응감측”적정의급범주，전청약품불량반응감측적개념。방법회고“감측”적어원학，이급작위술어재질병감측혹공공위생감측중적정의화범주；회고약품불량반응감측적역사여실천，이급신식기술발전대기적영향；분석“약품불량반응감측”、“약물경계”여“약물류행병학”적개념광가。결과“감측”적목표시유위해가능적추향。“지속”、“계통”、“수집”、“분석”、“해석”、“전파”시술어“감측”적기본원소。약품불량반응감측종약물획비상시즉개시，수집적수거불부섭급약물적성질，환섭급약품표준、약품생산、약품저존화약품사용。신식기술겁대지추동료약품불량반응감측。결론건의정의약품불량반응감측위：일항이약품불량반응위목표적공공위생항목，유일정투지속、계통성지수집、귀정、분석화천석약품대인체적위해방면적수거（포괄상관적지원보고、전자의료기록화실험실기록등）병급시향소유응해지도적인（감관부문、의무인원혹/화공음）반궤적과정조성。목적시인식약품안전문제적분포특정화변화추세，감별、평개、인식화교류약품비예기적유해작용，진일보인식약품적획익-풍험적속성，방범혹사약품적유해작용최소화。
Objective To clarify the definition and scope of "adverse drug reaction surveillance". Methods The etymology, usages, and previous definitions of 'surveillance' were examined. The history and practice of adverse drug reaction surveillance was reviewed and a distinction among the concept framework of "adverse drug reaction surveillance","pharmacovigilance" and"pharmacoepidemiology" was made. Results The targets of surveillance are harmful potentially; "ongoing","systematic", "collection", "analysis", "interpretation", and "dissemination" have been seen in any surveillance program. Surveillance starts as soon as the drug is first approved or at any time thereafter. The collected data involves not only the safety problems caused by the nature of the drug, but also related to drug standards, pharmaceutical production, drug storage and drug usages. Information technology has greatly promoted the surveillance. Conclusion Definition of adverse drug reaction surveillance is proposed: A public health program aimed to adverse drug reactions, consisting of a set of processes for the ongoing systematic collection, compilation, analysis, interpretation of drug safety data(including relevant spontaneous reports, electronic health records, and experimental data), closely integrated with the timely and coherent dissemination of the results and assessment to those (including regulators, healthcare professionals and public) who have the right to know so that action can be taken. The purpose is to learn the distribution and trend of drug safety, to identify, evaluate, understand, and communicate the unexpected adverse drug effects, to perfect the drug benefit -risk profile, in order to prevent or mitigate the harmful effects of drugs.