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

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。

Analysis of marked items for special population in drug package inserts of antimicrobial agents

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.