OBJECTIVE： To establish safety management mode of high-alert drugs in our hospital， and to guarantee the safety of drug use in clinic. METHODS： According to the JCI Hospital Appraisal Standard （fifth edition）， the management mode of high-alert drugs was established in our hospital. The problems of the management mode were analyzed according to implementation effects. PDCA cycle was used to optimize and improve the mode. The compliance rates of evaluation indicators were evaluated in each department within 10 months after improvement using 10 evaluation indexes， such as “having a clear list of high-alert medications”，“high-alert drug list in line with actual storage varieties”， “setting a special area or counter to store high-alert medications”，“having complete records about delivery and use of high-alert medication”. RESULTS： Through formulating the management system of high-alert drugs， our hospital conducted the management in respects of alerting， storage， prescription/medical order， dispensing， delivery， etc. After implementation， the management of high-alert drugs has been standardized and ordered； except for pharmacy department， there was still existing problems in the management of high-alert drugs in other departments. After using the PDCA cycle， the compliance rates of the 10 indicators in the eighth month had reached 100％ （except for pharmacy department， similarly hereinafter）； compared with the first month of compliance of 10 index （40.90％， 25.00％， 68.18％， 40.90％， 56.82％， 90.91％， 36.36％， 11.36％， 40.90％， 45.45％）， the difference was statistically significant （P＜0.05），which indicated effective improvement. The compliance rates of evaluation indicators were 100％ in ninth and tenth month， indicating continuous and stable effects. CONCLUSIONS： The management of high-alert drug established in our hospital is constantly improving and upgrading， and can provide better pharmaceutical care for patients.