Analysis and thinking on the status quo of safety item information in the instructions of traditional Chinese patent medicines containing Asari Radix et Rhizoma and its extracts

doi:10.19803/j.1672-8629.20230303

Abstract

Abstract: Objective To analyze the current situation of safety problems in the instructions of Chinese patent medicine containing Asari Radix et Rhizoma and its extracts, and to provide suggestions for the revision of instructions. Methods The Chinese pharmacopoeia 2020, Guidelines for clinical application of national essential drug 2012, Formulary of national essential drug were searched for Chinese patent medicines containing Asari Radix et Rhizoma and its extracts, and the composition and dosage, indications, usage and dosage of the Chinese patent medicine, and the safety information in the drug instructions were collected. Besides, the basic characteristics, dosage of Asari Radix et Rhizoma and safety items of Chinese patent medicine instructions were summarized and statistically analyzed in Excel 2019. Results 40 Chinese patent medicines containing Asari Radix et Rhizoma and its extracts were included after removing duplicates. The dosage of Asari Radix et Rhizoma from most of these Chinese patent medicines meets the regulations of Chinese pharmacopoeia, but there is a lack of the information on usage and dosage for special populations, “eighteen anti” and “nineteen fear”. There were still problems of the safety information of the drug instructions of the marketing authorization holders collected in this study including missing safety information and the nonstandard terminology. Conclusion We suggest the marketing authorization holders to revise the safety information of instructions based on related laws and regulations such as Technical Guiding Principles for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions (Trial) and the guidance of the syndrome differentiation system of traditional Chinese medicine and the clinical medication experience to provide foundation for safe use of clinical drugs. The safety information in the instructions includes adverse events, contraindications, precautions, warnings, application for specific populations, and usage and dosage for specific populations.

Key words: Asari Radix et Rhizoma, Chinese patent medicine, instruction, safety

CLC Number:

QIAO Meng, LEI Chao, CHEN Zijia, ZHANG Qiang, WANG Zhifei. Analysis and thinking on the status quo of safety item information in the instructions of traditional Chinese patent medicines containing Asari Radix et Rhizoma and its extracts[J]. Chinese Journal of Pharmacovigilance, 2023, 20(12): 1401-1406.

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