Analysis on Revision of Chinese Patent Medicine Instructions in China from 2010 to 2020 / 中国药房

ABSTRACT

OBJECTIVE：To furt her standardize and improve the drug instructions of Chinese patent medicine ，and to promote its clinical safe and rational use. METHODS ：The varieties of Chinese patent medicines with clear content revision issued by the website of the State Drug Administration from January 2010 to June 2020 were inquired. The revised contents ，characteristics and deficiencies were summarized and analyzed to put forward the revision suggestions. RESULTS & CONCLUSIONS ：Among 107 Chinese patent medicine varieties the instruction content of which were revised clearly ，safety items were the focus of revision ；106 types（99.07％）were revised in terms of “contraindications”，103 types（96.26％）were revised in terms of “precautions”，102 types（95.33％）were revised in terms of “ADR”，49 types（45.79％）were revised in terms of “warning words ”，etc. The main dosage forms involved in the revision were oral preparations ，followed by injections and a small amount of external/rectal/vaginal dosage forms. The revised content highlighted the TCM syndrome types applicable to Chinese patent medicine ，emphasized the precautions for the use of Chinese patent medicine containing toxic and chemical components and detailed the medication precautions for special groups. However ，there were still some problems ，such as lack of quantitative expression ，lack of systematic and comprehensive drug interaction tips ，and other related items that had not been revised needed to be improved. In order to promote the safe and rational use of Chinese patent medicine ，it is suggested that the revision of Chinese patent medicine instructions should focus on safe drug use ，provide clear ADR monitoring data ，clear and specific medication attention and systematic and comprehensive drug interaction.