Discussion on Some Problems of the Items in Chinese Patent Medicine Instruction in National Essential Medicine List
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Discussion on Some Problems of the Items in Chinese Patent Medicine Instruction in National Essential Medicine List
China PharmacyVol. 32, Issue 13, (2021)
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Published:2021,
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LI Chunxiao, SUN Jingya, LING Xiao, et al. Discussion on Some Problems of the Items in Chinese Patent Medicine Instruction in National Essential Medicine List. [J]. China Pharmacy 32(13).(2021)
DOI:
LI Chunxiao, SUN Jingya, LING Xiao, et al. Discussion on Some Problems of the Items in Chinese Patent Medicine Instruction in National Essential Medicine List. [J]. China Pharmacy 32(13).(2021)DOI:
Discussion on Some Problems of the Items in Chinese Patent Medicine Instruction in National Essential Medicine List
OBJECTIVE:To investigate and study the problems in the items labeling of Chinese patent medicine instructions in National Essential Medicines List ,and to provide reference for rational drug use and instruction revision. METHODS :Totally 268 Chinese patent medicines contained in the 2018 edition of National Essential Medicines List ,including 465 instructions of different . An dard docetaxel as first-line therapy in patients with meta - economic evaluation of docetaxel and paclitaxel regimens in metastatic breast cancer in the UK[J]. Pharmacoeco - dosage forms ,were collected ,and the labeling rate and content problems of drug instructions were counted. RESULTS :Of the 465 instructions,86.88% were labeled with cautions. The labeling rates of ADR ,pharmacokinetics,contraindications,drug interactions , clinical trials ,pharmacological toxicology and pharmacological action were low ,being 20.64%,0.21%,30.1%,1.07%,2.36%, 8.81%,1.93%. All other items were labeled. Incomplete description of ingredients ,incomplete information of decoction pieces and excipients accounted for 2.15% and 48.81%,respectively;the expression of functional indications was varied ,and there were 12 expression methods ,among which 16.5% of indications lacked TCM indications ;specifications were not uniform ,and there were 5 expression methods ;usage and dosage were not clearly marked ,and 465 instructions did not mention the usage and dosage for the elderly or pregnant and lactating women. Drug interactions ,ADR,matters needing attention and contraindications were not fully described with no substantive content ;only 0.64% marked interaction with chemical medicine and 12.68% marked contraindication content. CONCLUSIONS :There are some problems in the description of Chinese patent medicine instructions in 2018 edition of National Essential Medicine List ,such as non-standard and incomplete. It is suggested to strengthen efforts to establish and improve the information collection and feedback mechanism of Chinese patent medicine ,and introduce policies to support enterprises to carry out basic and clinical research after listing ;and through actively carrying out basic and clinical research in line with the characteristics of traditional Chinese medicine ,guided by the theory of traditional Chinese medicine ,combined with the latest research results ,so as to further improve the contents of Chinese patent medicine instructions.
关键词
国家基本药物目录中成药说明书合理用药特殊人群用药
Keywords
National Essential Medicine ListChinese patent medicine instructionRational drug useMedication for special