药品说明书中妊娠及哺乳期用药信息标注情况调查  

Investigation of drug use labeling for pregnant and lactating women in drug package inserts

作　　者：代雪飞[1] 王建青 DAI Xuefei;WANG Jianqing(Department of Pharmacy,The Fourth Affiliated Hospital of Anhui Medical University,Hefei,Anhui 230601,China)

机构地区：[1]安徽医科大学第四附属医院药剂科,安徽合肥230601

出　　处：《安徽医药》2020年第8期1669-1674,共6页Anhui Medical and Pharmaceutical Journal

摘　　要：目的调查药品说明书中关于妊娠及哺乳期用药信息的标注情况,提出标注建议,加强合理用药。方法统计安徽医科大学第四附属医院药品目录中1 541份药品说明书妊娠及哺乳期用药信息,调查2018年8月16日至2019年2月16日住院妊娠期病人使用的药物品种情况。结果西药说明书妊娠和哺乳期用药信息标注率分别为84.02%、78.75%,中成药分别为50.74%,14.81%;妊娠及哺乳期药品说明书普遍存在缺乏人体试验信息、FDA妊娠分级标注率低、不同妊娠分期标注率低、缺乏妊娠及哺乳期药代动力学研究、用药指导不确定性标注率高等问题;有妊娠及哺乳期用药信息的药品以口服给药及静脉给药比例较高,外用及其他剂型比例较低;非处方药妊娠及哺乳期用药信息标注率低;妊娠期住院病人所用部分药品在妊娠期使用的安全性尚未确立,部分药品对胎儿有潜在风险。结论常用药品说明书妊娠及哺乳期用药信息标注率不佳,需要药品监管部门、药品研发生产企业、医疗机构共同推动药品说明书关于妊娠及哺乳期用药信息的完善,保障特殊人群合理用药。Objective To analyze and evaluate the labeling information of the drug instructions for women in pregnancy and lactation,and to put forward suggestions for labeling to promote rational drug use.Methods Statistical analysis was made of the drug directory of The Fourth Affiliated Hospital of Anhui Medical University,summarizing a total of 1 541 medication information for women in pregnancy and lactation,and investigating the drug use among 119 pregnant inpatients hospitalized from August 16,2018 to February 16,2019.Results The rates of drug use labeling for pregnant and lactating women in Western medicine instructions and Chinese patent medicine instructions were 84.02%,78.75%,and 50.74%,14.81%,respectively.The common problems in drug instructions for pregnant and lactating women were lack of the information of human test,low labeling rate of FDA pregnancy grading,low labeling rate of different pregnancy staging,lack of pregnancy and lactation pharmacokinetic study,high rate of drug guidance uncertainty.Drugs with use instructions for pregnant and lactating women were more drugs for oral administration and intravenous administration than drugs for external use and other dosages.The labeling rate of non-prescription drugs for pregnancy and lactation was low.Some drugs used by inpatients during pregnancy had uncertainty in safety and some drugs pose a potential risk to the fetus.Conclusion Drug regulatory authorities,drug research and development enterprises,and medical institutions are required to jointly promote the drug use information for women in pregnancy and lactation,and to ensure the rational use of drugs for special populations.

关 键 词：药物标签 说明书 妊娠期 哺乳期 用药信息 

分 类 号：R95[医药卫生—药学]