皮肤科常用药品说明书儿童用药信息标注情况分析
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欧文(1988.6-),女,广西南宁人,本科,主管药师,主要从事临床药学的研究

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R986

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Investigation and Analysis of Medication Information Labeling for Children in Commonly Used Dermatology Drug Instructions
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    摘要:

    调查并总结我院皮肤科常用药品说明书中儿童用药信息标注情况,为规范说明书标注信息 提供参考。方法 收集我院2021-2023年皮肤科常用使用的药品说明书,对说明书中适应证、用法用量、不 良反应、禁忌证、注意事项、儿童用药、药物过量、临床试验、药理毒理、药代动力学项目中提及儿童用 药信息进行分析。结果 收集到的156份涉及儿童用药信息的说明书中,儿童用药信息标注儿童用药项占 比72.44%,其中明确标注儿童用药信息的仅占20.51%,用法用量项占比35.26%,注意事项项占比39.74%, 其余项目占比均低于10%。在各类别药物的药品说明书中,皮肤科用药药品说明书中“儿童用药”项标注 率最低,仅42.86%。药品说明书最后修订日期距今间隔时间不同,其中1年内修订比例最低,而进口药说明 书修订比例高于国产药,处方药说明书修订比例高于非处方药。结论 皮肤科常用药物的药品说明书中儿 童用药信息标注率整体偏低、标注的儿童用药信息指导作用不大、说明书修订不及时,儿童用药信息的标 注情况和指导性内容仍需进一步完善,同时行政主管部门要加强监管审批力度。

    Abstract:

    To investigate and summarize the labeling of children's medication information in the instructions of commonly used drugs in dermatology department of our hospital, so as to provide reference for standardizing the labeling information of instructions. Methods The instructions of commonly used dermatology drugs in our hospital were collected, the medication information mentioned children in items such as “indications dosage” “adverse reactions” “contrain dications”“preca utions”“children's medication”“drug overdose”“clinical trials”“pharmacological toxicology”“pharmacokinetics” etc. was carried on. Results The labeling rate of medication information for children was 72.44% among the collected 156 kinds of dermatology drug instructions. Of which 20.51% were specifically labeling on item of “children's medication”, 35.26% were labeling on item of “indications dosage”, 39.74% were labeling on item of “precautions”, and less than 10% were labeling on the rest items. Among the drug instructions of various types of drugs, the labeling rate of “children's medication” in the drug instructions of dermatology was the lowest, only 42.86%. The time interval between the last revision date of the drug instructions and the present was different. Among them, the proportion of revisions within 1 year was the lowest, while the proportion of revisions of imported drug instructions was higher than that of domestic drugs, and the proportion of revisions of prescription drug instructions was higher than that of non-prescription drugs. Conclusion The labeling rate of medication information for children is generally low, the guidance significance of the labeling medication information for children was little, and the drug instructions were not revised in time. It is suggested that the labeling and guiding contents of medication information for children still needs to be further improved, and the administrative department should strengthen the supervision and approval.

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欧文.皮肤科常用药品说明书儿童用药信息标注情况分析[J].医学美学美容,2024,33(4):120-123.

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  • 在线发布日期: 2024-03-12
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