摘要
《中华人民共和国药品管理法》第十二条规定,“国家建立药物警戒制度,对药品不良反应及其他与用药有关的有害反应进行监测、识别、评估和控制”。药物警戒贯穿从药物研发到使用的全生命周期,其核心思想是防控用药风险,保障患者与公众安全。医疗机构是药品使用的主要场所,是药物警戒活动的关键参与方,其药物警戒体系构建是国家药物警戒制度建设的重要一环。当前,正值我国药物警戒制度实施的起步阶段,为推动医疗机构药物警戒体系建设,国内药物警戒监测机构、相关学术团体、高等医药院校、杂志社和社会公益组织共同发起,邀请相关领域的专家学者们共同研讨,集思广益,辨析药物不良反应/事件、用药安全和药物警戒等的重要理念以及前沿发展,编写了《医疗机构药物警戒体系建设专家共识》,提出了较为系统的医疗机构药物警戒体系建设的原则与方法,以期对医疗机构药物警戒体系建设有所帮助。
As stated by article 12 of the drug administration law of the People’s Republic of China, the state shall construct pharmacovigilance regulations to monitor, identify, assess, and control adverse drug reactions and other harmful events related to medication. Pharmacovigilance runs throughout the whole life cycle of drug from research and development to clinical use, and the core idea is to prevent and control medication risks and ensure the safety of patients and the general public. As the main places for drug consumption and the key participants in pharmacovigilance activities, the construction of pharmacovigilance system in health facilities is an important part in the construction of national pharmacovigilance regulations. At present, we are at the initial stage of the implementation of national pharmacovigilance regulations. In order to promote the establishment of pharmacovigilance system in health facilities, domestic pharmacovigilance monitoring institutions, relevant academic groups, medical colleges and universities, periodical offices, and social welfare organizations jointly initiate the compilation of expert consensus on construction of pharmacovigilance system in health facilities by inviting experts and scholars in relevant fields to discuss, distinguish, and analyze the important concepts on adverse drug reactions/events, medication safety, pharmacovigilance, etc., in combination with cuttingedge developments. The consensus puts forward systematic principles and methods on establishing pharmacovigilance system,expecting to provide reference to health facilities in pharmacovigilance system establishment.
作者
国家药品监督管理局药品评价中心
中国药师协会
中国药学会医院药学专业委员会
中国药学会药物警戒专业委员会
中国毒理学会临床毒理专业委员会
中国研究型医院学会药物评价专业委员会
中国医药教育协会药物警戒评价分会
中国药理学会药源性疾病学专业委员会
中国抗癌协会肿瘤临床药学专业委员会
合理用药国际网络中国中心组临床安全用药组
北京大学医学部药物评价中心
中国药科大学药品监管科学研究院
药物不良反应杂志社
《中国药物应用与监测》杂志
北京市药学质量控制和改进中心
广东省药学会
北京药学会
上海市药学会
四川省药学会
四川省药理学学会
湖南省药学会
辽宁省药学会
河南省药学会
北京药盾公益基金会
张晓乐
柳鹏程
朱珠
刘芳
Center for Drug Reevaluation,National Medical Products Administration;Chinese Pharmacists Association;Hospital Pharmacy Committee of Chinese Pharmaceutical Association;Pharmacovigilance Professional Committee of Chinese Pharmaceutical Association;Committee of Clinical Toxicology,Chinese Society of Toxicology;Drug Evaluation Committee of Chinese Research Hospital Association;Pharmacovigilance Evaluation Branch of China Medicine Education Association;Chinese Pharmacological Society Professional Committee of Drug-induced Diseases;Oncology Clinical Pharmacy Committee,China Anti-Cancer Association;Medication Safety Panel in China Core Group of International Network for the Rational Use of Drugs;Drug Evaluation Division of Peking University Health Science Center;Institute of Regulatory Science of China Pharmaceutical University;Adverse Drug Reactions Journal Agency;Chinese Journal of Drug Application and Monitoring;Beijing Pharmacy Center for Quality Control and Improvement;Guangdong Pharmaceutical Association;Beijing Pharmaceutical Association;Shanghai Pharmaceutical Association;Sichuan Pharmaceutical Association;Sichuan Pharmacological Society;Hunan Phannaceutical Association;Liaoning Pharmaceutical Association;Henan Pharmaceutical Association;Peking Safety Medicine Foundation
出处
《中国药物应用与监测》
CAS
2022年第3期135-144,共10页
Chinese Journal of Drug Application and Monitoring
关键词
药物警戒
医疗机构
风险管理
药物不良反应
药物不良事件
Pharmacovigilance
Health facilities
Risk management
Adverse drug reaction
Adverse drug event
作者简介
通信作者:张晓乐,男,副主任药师,研究方向:医院药学与药事管理。E-mail:xiaolezhang@126.com;柳鹏程,男,副教授,研究方向:药物警戒与真实世界研究。E-mail:liupcmail@163.com;朱珠,女,研究员,研究方向:临床药动学与药物利用评价研究、药物安全性评价、流程管理与精细化管理。E-mail:zhuzhu@pumch.cn;刘芳,女,主任药师,研究方向:用药安全与循证药学。E-mail:liufang8-111@163.com。
