抗微生物药物说明书中关于特殊人群用药标注项目的调查分析
Analysis of marked items for special population in drug package inserts of antimicrobial agents
-
摘要: 目的 考察抗微生物药物说明书中关于特殊人群用药标注项目情况,为进一步规范说明书提供参考。 方法 收集抗微生物药物说明书185份,对其中的孕妇及哺乳期妇女用药、儿童用药以及老年用药进行统计分析。 结果 说明书中孕妇及哺乳期妇女用药项多有标注,标注为尚不明确的比例不高;儿童用药项标注尚不明确或部分年龄(月龄、日龄)尚未确定的比例较高,有些药物的用法用量项下对儿童用药未进行标注,有的标注不够详尽规范;老年用药项标注用法用量的比例较高。 结论 药品说明书须不断地加以完善,以确保用药安全。Abstract: Objective To investigate and analyze the current package inserts of antimicrobial agents and provide references for the further standardization of drug package inserts. Methods A total of 185 package inserts of antimicrobial agents were collected and the marked items of drug use for pregnant and lactating women, paediatric patients, and geriatric patients were analyzed respectively. Results Among the package inserts, most marked items for drug use were found in pregnant and lactating women items, the proportion of which the marked items were still unknown was lower; it had higher proportion that marked items not yet established for drug use for all or part of age (month old, day old) paediatric patients in paediatric use items, and in some drug package inserts which were marked items lackage for drug use for paediatric patients in dosage and administration items, or marked not detailed and standard; moreover there was higher proportion of labeling as to dosage and administration in geriatric use items. Conclusion It was necessary to improve the drug package inserts continually so as to ensure the drug use safety.
-
Key words:
- antimicrobial agents /
- package inserts /
- special population /
- investigation and analysis
-
[1] 谢松梅,杨进波,赵 明,等. 我国抗菌药物说明书临床内容的撰写要求[J]. 中国临床药理学杂志,2008,24(6):574. [2] 苏洽玉,陈海坤. 558份化学药品说明书的调查分析[J]. 中国药房,2008,19(4):316. [3] 中华医学会,中华医院管理学会药事管理专业委员会,中国药学会医院药学专业委员会. 抗菌药物临床应用指导原则[S].2004. [4] 胡德荣. 儿童用药存在的问题及建议[J]. 咸宁学院学报(医学版),2009,23(1):51. [5] 吴康郁,吴雪茹,谭活玲,等. 注射剂药品说明书的调查与分析[J]. 中国中医药现代远程教育,2008,6(12):1465. [6] 孙向东,胡德华,罗欢坤. 国内外网站药物说明书标注项目的调查分析[J]. 预防医学情报杂志,2006,22(1):52.
计量
- 文章访问数: 2747
- HTML全文浏览量: 220
- PDF下载量: 283
- 被引次数: 0