Analysis on the Publication of Revision Notices of Drug Instructions and Related Status in China in 2015-2019
- VernacularTitle:2015－2019年我国药品说明书修订通告发布情况及相关现状分析
- Author:
Yanqiu LIU
1
;
Zhongjuan WANG
1
;
Yueqin LIANG
1
Author Information
1. Dept. of Pharmacy，Yan’an Hospital of Kunming City，Kunming 650051，China
- Publication Type:Journal Article
- Keywords:
Drug instructions;
Revision notice;
Management;
Analysis
- From:
China Pharmacy
2019;30(21):2903-2908
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE： To analyze the situation of drug instruction revision and promote the standardization. METHODS： By reviewing the laws and regulations on the management of drug instructions in China， inquiring the official documents of drug instruction revision during Jan. 2015 to May 2019， the types of drugs involved and the revised items were analyzed， and the contents and shortcomings of the drug instructions and their revision process were summarized. RESULTS： A total of 112 revision notices were issued in 5 years （20， 28， 19， 34， 11 revision notices in 2015-2019， respectively）， involving 270 varieties. There were 109 prescription drugs， 161 OTC， 158 Chinese medicines， 105 chemicals， and 2 biological products. The revised items mainly focus on safety information such as precautions， adverse reactions， contraindications， and additional warnings， including 100， 85， 103， 52 items. However， in combination with clinical practice， the author found that there were still some problems， such as non-standard writting drug instructions， lack of supervision on the implementation of the revision， and no notification to the relevant users after the revision， which seriously threatened the safety of drug use. CONCLUSIONS： The included specifications of drug instructions are not well regulated， the implementation of the revised instructions is not doing well， the delineation of rights and obligations is confused， and the legal binding force is not strong. The standardization of drug instructions in China needs further improvement.
