董卫华 1董占军 2孙路路 3赵颖波 3薛焯尹 1刘敏 1封卫毅1
作者信息
- 1. 西安交通大学第一附属医院药学部,西安 710061
- 2. 河北省人民医院药学部,石家庄 050051
- 3. 国家卫生健康委医院管理研究所/国家药事管理专业医疗质量控制中心,北京 100044
- 折叠
摘要
Abstract
OBJECTIVE To formulate the Hazardous Drug List in China,and provide a scientific basis for standardizing the management of hazardous drugs,preventing and controlling occupational exposure risks in medical institutions at all levels in China.METHODS Under the joint organization of the Intravenous Medication Admixture Management Professional Committee of the Chinese Pharmaceutical Association and the National Medical Quality Control Center for Pharmaceutical Management,based on literature research and international hazardous drug lists and their development procedures,the scope of hazardous drug selection,selection principles,and evidence confirmation criteria were determined through expert panel seminars and expert questionnaire survey method(Delphi method).Chemical drugs,biological agents,and Chinese patent medicines marketed in China that met the selection principles were screened to form the Chinese Expert Consensus on the Hazardous Drug List.RESULTS Five principles for selecting hazardous drugs were established(including protective labeling in package inserts,carcinogenicity,reproductive toxicity,genotoxicity,and organ toxicity at low doses),along with the corresponding evidence confirmation criteria.The Hazardous Drug List containing 210 drugs was formulated,covering anti-tumor drugs,endocrine system drugs,nervous system drugs,immunomodulators,anti-infective drugs,cardiovascular system drugs,hematological system drugs,urinary system drugs,obstetrics and gynecology drugs,dermatological drugs and other categories.Compared with international hazardous drug lists,25 newly included hazardous drugs were added,including 15 anti-tumor drugs,6 Chinese patent medicines and 4 biological agents.In addition,88 Chinese patent medicines that may have potential occupational exposure risks are listed in the appendix for reference by medical institutions in management.CONCLUSIONS The development of this consensus closely aligns with the actual clinical drug use in China,with a scientific and rigorous methodology,and can serve as a reference for medical institutions at all levels to standardize the management of hazardous drugs and prevent and control occupational exposure risks.关键词
危害药品/目录制定/职业防护/中成药/国产创新药Key words
hazardous drugs/list formulation/occupational protection/Chinese patent medicines/domestic innovative drugs分类
医药卫生
