Safety Information in Oral Chinese Patent Medicine Instructions for Big Brand Traditional Chinese Medicine

doi:10.19803/j.1672-8629.2021.10.19

Abstract

Abstract: Objective To summarize and analyze the integrity, standardization and rigor of the safety information of oral Chinese patent medicines that are listed among the top 100 in the scientific and technological competitiveness of major varieties of big brand traditional Chinese medicine, and to provide reference for the clinical safe use and development and application of oral Chinese patent medicines. Methods 95 copies of the current drug instructions of oral Chinese patent medicines that are listed among the top 100 in the scientific and technological competitiveness of major varieties of big brand traditional Chinese medicine were collected, then the security information, including ingredients, adverse reactions, contraindications, cautions, medication tips for special populations, drug interactions, clinical trials and pharmacological toxicology reports, warnings were statistically analyzed, then the security information, including ingredients, adverse reactions, contraindications, cautions, medication tips for special populations, drug interactions, clinical trials and pharmacological toxicology reports, warnings were statistically analyzed. Results There exit some medicine instructions lack of warnings for toxic and powerful drugs and the eighteen incompatible medicaments &the nineteen medicaments of mutual restraint drugs. Adverse reactions, cautions, and contraindications were not clear. Invalid information exists in cautions, drug interactions, and warnings. Conclusion The safety information of oral Chinese patent medicine specifications should be standardized, so as to provide basis for rational drug use by doctors and patients.

Key words: oral Chinese patent medicine, medicine instructions, safety information, big brand traditional Chinese medicine, scientific and technological competitiveness

CLC Number:

R994.11

ZHOU Sha, YANG Hongjun, JING Zhiwei, LI Geng. Safety Information in Oral Chinese Patent Medicine Instructions for Big Brand Traditional Chinese Medicine[J]. Chinese Journal of Pharmacovigilance, 2021, 18(10): 981-985.

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