Management of risks to pediatric medications based on drug instructions of Chinese patent medicines in a hospital

doi:10.19803/j.1672-8629.20230625

Abstract

Abstract: Objective To investigate the types, drug instructions and current usage of Chinese patent medicines for pediatric use in our hospital, analyze the risks, and provide data for safe and rational use of pediatric drugs. Methods The way in which 128 types of Chinese patent medicines were used in our hospital was investigated. The labeling of usage and dosage, adverse reactions, contraindications, precautions, drug interactions, clinical trials or pharmacology and toxicology in the instructions were analyzed. Prescriptions of traditional Chinese patent medicines given by outpatient and emergency departments in June and October 2021 were randomly selected to find out whether these prescriptions were up to standard and proper before the potential risks to pediatric drugs were explored. Results Among the 128 types of Chinese patent medicines, 54 were children specific medicines, accounting for 42.19%. There were 47 types of drugs containing toxic decoction pieces, involving 21 types of toxic Chinese medicinal materials. According to the survey on the contents marked in the instructions, 52.35% of the drugs were marked with clear usage and dosage for children, and 32.03%, 32.81% and 82.03% of the drugs labeled with adverse reactions, contraindications and precautions, respectively. The rate at which drug interactions, clinical trials or pharmacological and toxicological labeling were specified was not high. Improper prescriptions of Chinese patent medicines in the outpatient and emergency departments included the lack of diagnosis by TCM clinicians and inappropriate use and dosage. There were some drug risks. Conclusion The limited diversity of traditional Chinese patent medicines and the lack of information on children's drug use in the instructions can increase the risk of clinical drug use. It is recommended that the research and development of children specific drugs be enhanced and multi-dimensional research be conducted to supplement the information on traditional Chinese patent medicines for children. Based on the characteristics of children's s bodies, conditions and medications, pharmacists should provide targeted, refined and personalized pharmaceutical service, strengthen the supervision and guidance of drug use for children, and ensure the rational and safe use of drugs for children.

Key words: Chinese patent medicines, drug instructions, pediatrics, children, prescriptions, risk analysis, risk management

CLC Number:

R994.11
R985

LIU Jie, ZHANG Jianmin, ZHANG Xiaomeng, LIU Fang, SONG Yuan, ZHONG Xuli. Management of risks to pediatric medications based on drug instructions of Chinese patent medicines in a hospital[J]. Chinese Journal of Pharmacovigilance, 2024, 21(4): 422-427.

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https://www.zgywjj.com/EN/Y2024/V21/I4/422

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