| 摘要: |
| 目的:探讨药品说明书与 2020 版《中华人民共和国药典临床用药须知》 (简称《临床用药须知》)中儿童禁用信息的差 异,为儿科临床药物治疗和药品说明书中儿童禁用信息的完善提供参考。 方法:对 2020 年版《中华人民共和国药典》收载的化 学药品与生物制品,国家基本医疗保险、工伤保险和生育保险药品目录(2023 年) (NRML-2023,含协议期内谈判药品和竞价药 品)西药部分药品说明书中标注为儿童禁用的药品,收集并分析药品说明书中儿童禁用信息与《临床用药须知》中儿童用药信 息的差异。 结果:药品说明书一致标注为儿童禁用的品种共有 222 个,185 个药品收载于《临床用药须知》,涉及 19 个类别。 185 个药品中 154 个标注儿童禁用,占比 83. 24%(154 / 185);31 个未标注儿童禁用,占比 16. 76%(31 / 185)。 154 个标注儿童禁 用的药品中,对于儿童禁用年龄段,144 个与说明书一致,10 个与说明书不一致。 144 个药品中,27 个禁用年龄虽与说明书一 致,但《临床用药须知》提供了该年龄段儿童国外的适应证或者超说明书适应证;对于儿童禁用原因,77 个说明书和《临床用药 须知》均未标注,28 个在说明书与《临床用药须知》中均有标注且儿童禁用原因一致,43 个仅在药品说明书中标注,6 个仅在《临 床用药须知》中标注。 31 个未标注儿童禁用的药品中,12 个提供了说明书儿童禁用年龄段内的用药数据。 结论:药品说明书与 《临床用药须知》儿童禁用信息标注存在差异,应完善儿童禁用原因、规范儿童禁用信息标注,保障儿童用药的可及性和安全性。 |
| 关键词: 儿童 药品说明书 临床用药须知 禁用信息 差异 |
| DOI：doi:10.13407/j.cnki.jpp.1672-108X.2024.07.009 |
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| 基金项目:国家“十三五”科技重大专项增补任务,编号 2017ZX09304029-001-001 |
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| Differences of Contraindications Information in Children between Drug Instructions and Chinese Pharmacopeia Guidelines for Clinical Drug Use |
| Zhang Yunxia, Qin Qianqian, Zhao Ruiling |
| (( Shanxi Children’ s Hospital, Shanxi Women and Children Hospital, Taiyuan 030013, China)) |
| Abstract: |
| Objective: To probe into the differences of contraindications information in children between drug instructions and 2020 edition of Chinese Pharmacopeia Guidelines for Clinical Drug Use (hereinafter referred to as “Guidelines for Clinical Drug Use”), so as to provide reference for pediatric clinical drug treatment and improvement of information for children’ s contraindications in drug instructions. Methods: Chemicals and biological products from 2020 edition of Chinese Pharmacopeia, drugs labeled as contraindications for children in some drug instructions of Western medicines from 2023 edition of National Reimbursement Medicine List (NRML-2023, including negotiated drugs and bidding drugs during the agreement period ) were collected. Differences of contraindications information in children in the drug instructions and drug information for children in the Guidelines for Clinical Drug Use were analyzed. Results: There were 222 drugs labeled as contraindications in children in the drug instructions, and 185 drugs were listed in in Guidelines for Clinical Drug Use, including 19 categories. Of the 185 drugs, 154 were labeled as contraindications in children, accounting for 83. 24% ( 154 / 185), and 31 were not labeled as contraindications in children, accounting for 16. 76% (31 / 185). Of the 154 drugs labeled as contraindications in children, for the age group of contraindications in children, 144 drugs were consistent with drug instructions and 10 drugs were inconsistent with drug instructions. Of the 144 drugs, 27 drugs had a prohibited age that was consistent with the drug instructions, yet the Guidelines for Clinical Drug Use provided a foreign indication or off-label indication for children in that age group. For the reasons of contraindications for children, 77 were not labeled in drug instructions and Guidelines for Clinical Drug Use, 28 were labeled in both the drug instructions and Guidelines for Clinical Drug Use, the reasons of contraindications for children were the same, 43 were labeled only in the drug instructions, and 6 were labeled only in the Guidelines for Clinical Drug Use. Of the 31 drugs that were not labeled as contraindicated in children, 12 provided data on the use of drugs within the prohibited age group of children in drug instructions. Conclusion: There are differences of contraindications information in children between drug instructions and Guidelines for Clinical Drug Use. It is necessary to improve the reasons for children’s contraindications, standardize the labeling of children’s contraindications information, and ensure the accessibility and safety of medication |
| Key words: children drug instructions Guidelines for Clinical Drug Use contraindications information differences |
