复旦大学附属妇产科医院609份药品说明书中有关妊娠期及哺乳期妇女用药标注调查

目的：了解药品说明书中有关妊娠期及哺乳期妇女用药的标注情况，促进药品说明书规范化管理，为临床安全用药提供参考依据。方法：收集我院调剂药房药品说明书，对有关妊娠期及哺乳期妇女用药标注情况进行统计分析，按照不同分类方法进行比较。结果：所调查的药品说明书中，国产化学药及生物制品有关妊娠期及哺乳期妇女用药标注率分别为95.91％和80.56％，进口药为98.02％和87.13％，国产中成药为68.38％和6.84％。妊娠期及哺乳期妇女用药无明确指导意见的分别占26.11％和49.26％。“权衡利弊”“慎用”及“遵医嘱”等类似表述在用药指导建议中最为常见。结论：药品监管部门、生产企业和医疗卫生机构应重视目前部分药品说明书标注存在的问题，积极采取措施加以改进和完善。

Analysis of Labeling on Drug Use for Pregnant and Lactating Women in 609 Drug Package Inserts in Hos- pital for Obstetrics and Gynaecolo~y Affiliated to Fudan University.

OBJECTIVE： To investigate the labeling on drug use for pregnant and lactating women so as to facilitate the stan- dardized management on drug package inserts and provide reference for clinical rational use of drugs. METHODS： The drug pack- age inserts in dispensing pharmacy of our hospital were reviewed with the labeling of drug use for pregnant and lactating women an- alyzed statistically and compared in accordance with different classification methods. RESULTS： Of all the package inserts investi- gated, labeling on drug use for pregnant and lactating women was noted in the package inserts of 95.91% vs. 80.56% of domestic chemical drugs and biological products, 98,02% vs. 87.13% of the imported drugs and 68.38% vs. 6.84% of the Chinese patent medicines, There was no clear labeling on drug use for pregnant and lactating women in 26.11% vs. 49.26%. The most common in- structions labeled included ＂weigh the merits and demerits＂, ＂be used with caution＂, ＂follow the doctor＇ s advice＂ and other simi- lar statements. CONCLUSIONS： Drug control authorities, drug manufacturers and medical institutions should pay attention to the problems noted in the labeling for pregnant and lactating women and take actively measures to improve and perfect drug labeling.