Chinese expert consensus on the Hazardous Drug List
- VernacularTitle:《危害药品目录》中国专家共识
- Author:
Weihua DONG
1
;
Zhanjun DONG
2
;
Lulu SUN
3
;
Yingbo ZHAO
3
;
Zhuoyin XUE
1
;
Min LIU
1
;
Weiyi FENG
1
Author Information
1. Dept. of Pharmacy，the First Affiliated Hospital of Xi’an Jiaotong University，Xi’an 710061，China
2. Dept. of Pharmacy，Hebei General Hospital，Shijiazhuang 050051，China
3. Dept. of Pharmaceutical Administration and Research，National Institute of Hospital Administration/National Center for Medical Quality Control in Pharmaceutical Management，Beijing 100044，China
- Publication Type:Journal Article
- Keywords:
list formulation;
occupational protection;
Chinese patent medicines;
domestic innovative drugs
- From:
China Pharmacy
2026;37(12):1521-1527
- CountryChina
- Language:Chinese
-
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 selecti on 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.
