Risk analysis and suggestions of 570 drug wholesale enterprises in Hunan province
- VernacularTitle:湖南省570家药品批发企业风险情况分析及建议
- Author:
Le HAI
1
;
Dan HUANG
2
;
Dan WANG
2
;
Yong YU
3
;
Xinwen LIN
1
Author Information
1. Hunan Drug Inspection Center，Changsha 410006，China
2. Inspection Branch of Hunan Medical Products Administration，Changsha 410013，China
3. College of Pharmacy，Hunan Food and Drug V ocational College，Changsha 410208，China
- Publication Type:Journal Article
- Keywords:
Hunan province;
drug wholesale enterprises
- From:
China Pharmacy
2022;33(4):403-407
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To provi de reference for standardizing the distribution behavior of drug wholesale enterprises and improving the supervision level of drug supervision departments. METHODS The defective items found in the on-site inspection of 570 drug wholesale enterprises in Hunan province in 2020 were summarized ，the main risks were analyzed to put forward countermeasures and suggestions. RESULTS & CONCLUSIONS The provincial drug regulatory departments conducted daily supervision and inspection among 192 drug wholesale enterprises ，of which 168 enterprises（87.50％）were ordered to make corrections；a total of 1 804 defective items were found ，involving 11 serious defects ，806 major defects and 987 general defects. The provincial drug regulatory departments conducted special inspections among 20 wholesale enterprises of narcotic drugs and psychotropic drugs ，of which 18 enterprises（90.00％）were ordered to make corrections ；a total of 48 defective items were found ， involving 33 major defects and 15 general defects ，and no serious defective items were found. The drug regulatory departments of all cities （autonomous prefectures ）inspected 358 drug wholesale enterprises ，of which 290 enterprises（81.00％）were ordered to make corrections ；a total of 1 499 defective items were found ，including 665 main defects and 834 general defects ，and no serious defective items were found. According to the statistics of occurrence frequency ，defective items of drug wholesale enterprises in Hunan province were mainly concentrated in storage and maintenance （687 items，20.50％），facilities and equipments （608 items， 18.14％），personnel and training （579 items，17.28％），receipt and acceptance （272 items，8.12％）and quality management system documents （260 items，7.76％），which together accounted for 71.80％ of the total defects. The main risks of drug wholesale enterprises included weak enterprise risk awareness ，high frequency of quality risks in drug marketing ，imperfect enterprise quality management system documents ，and fraud in enterprise business behavior. It is recommended that drug wholesale enterprises should establish quality risk management institutions ，evaluation standards and management systems ，improve the operation quality management system ，strengthen the management of drug storage ，standardize the operation and management of enterprises，strengthen personnel training and standardize procurement behavior ，so as to j ointly maintain the safety and efficacy of drugs and controllable quality.
