1. 基于中成药说明书 “警示语” 完善的临床药学服务策略.
- Author
-
张冰, 吴昊, 张晓朦, and 林志健
- Subjects
- *
CHINESE medicine , *MEDICATION safety , *TECHNICAL specifications , *PHARMACEUTICAL services , *GOVERNMENT agencies , *DRUG registration - Abstract
The “warnings” section in medicine instructions is an important part that all national drug regulatory agencies use to ensure drug safety. This paper sorted out 12 laws, regulations and guidelines related to the “warnings” of drug instructions in 6 representative countries in Europe, America, Oceania, and Asia, and compared their expression and format requirements to provide reference for the improvement of the “ warning” terms in the instructions of Chinese patent medicines. Technical Specification for Revision of Safety Information in the Marketed Chinese Patent Medicine Instructions- Warnings (T/ CACM 1370. 6-2021) provided enlightenment for revising and improving the instructions in terms of the problems such as incomplete labelling of the “warnings”. We explored the strategy of clinical pharmaceutical service based on “warning” terms, and proposed to carry out the whole process of clinical pharmaceutical service based on the principles of “ monitoring, follow-up research, and international reference", and provide the most direct medication guidance for physicians, pharmacists, nurses, and patients to ensure the safe and rational medication in clinical practices, and to improve the quality of clinical pharmaceutical care. [ABSTRACT FROM AUTHOR]
- Published
- 2022
- Full Text
- View/download PDF