传统免疫抑制剂药品说明书妊娠期及哺乳期用药信息标注情况分析  

Analysis of Medication Information Labeling for Pregnant and Lactating Women in the Instructions of Traditional Immunosuppressants

作　　者：谢洪梅 钱火连 陈秋娟 王强 XIE Hongmei;QIAN Huolian;CHEN Qiujuan;WANG Qiang(The Second Affiliated Hospital of Army Medical University,Chongqing,China 400037)

机构地区：[1]中国人民解放军陆军军医大学第二附属医院,重庆400037

出　　处：《中国药业》2024年第4期10-13,共4页China Pharmaceuticals

基　　金：重庆市临床药学重点专科建设项目[渝卫办发﹝2021﹞52号]。

摘　　要：目的分析传统免疫抑制剂药品说明书中妊娠期及哺乳期女性用药信息的标注情况。方法收集医脉通官方网站收录的免疫抑制剂的药品说明书,通过药智数据(网页版)、用药助手手机软件及纸质药品说明书进行逐一核实后,参照《化学药品和治疗用生物制品说明书规范细则》提取并整理传统免疫抑制剂药品说明书“妊娠期用药”“哺乳期用药”项下的用药标注情况。检索时间为2022年10月31日。结果共收集到123份药品说明书。标注“妊娠期用药”和“哺乳期用药”项的分别有100份(81.30%)和96份(78.05%),其中分别有95份(77.24%)和93份(75.61%)有用药指导意见。26份药品说明书因药品的剂型、厂家不同而在“妊娠期用药”项标注内容存在差异(涉及氟尿嘧啶、环孢素、羟基脲、他克莫司),但“哺乳期用药”项标注内容均一致(均为不应哺乳或停止用药)。结论我国部分传统免疫抑制剂的药品说明书标注内容存在“妊娠期用药”“哺乳期用药”项信息缺失、指导意见不明确、部分药品说明书标注内容不一致、哺乳期用药标识滞后等问题,应引起药品监管部门和药品上市许可持有人的重视,并不断加强对药品说明书的管理和规范。Objective To analyze the labeling of medication information for pregnant and lactating women in the instructions of traditional immunosuppressants.Methods The information of immunosuppressant instructions were collected from the medlive.cn and checked by the db.Yaozhi.com,medicine helper App and paper-based drug instructions in October 31,2022.The medication labeling information for pregnant and lactating women in the instructions of traditional immunosuppressants was extracted and summarized based on the Specification Rules on Instructions of Chemical Drugs and Biological Products for Therapeutic Use.Results A total of 123 drug instructions were collected.There were 100 and 96 drug instructions(81.30%and 78.05%)were labeled with medication information for pregnant and lactating women respectively,of which 95 and 93 drug instructions(77.24%,75.61%)contained medication guidance respectively.A total of 26 drug instructions had different medication information for pregnant women due to different dosage forms and manufacturers,involving fluorouracil,ciclosporin,hydroxycarbamide and tacrolimus,while their medication information for lactating women was consistent,that was lactation or medication was not allowed.Conclusion There are some problems in the labeling of medication information for pregnant and lactating women in the instructions of some traditional immunosuppressants in China such as missing information,unclear guidance,inconsistent labeling in some drug instructions and delayed medication labeling for lactating women.Drug regulatory departments and marketing authorization holders should pay attention to these problems,and strengthen continuously the management and standardization of drug instructions.

关 键 词：妊娠期 哺乳期 传统免疫抑制剂 药品说明书 用药信息 

分 类 号：R95[医药卫生—药学]