抗抑郁药品说明书中妊娠哺乳期用药信息标注情况分析

Statistical analysis of medication information labeling of pregnant women and lactating women in the instructions of antidepressant drugs

目的为规范抗抑郁药品说明书中妊娠哺乳期妇女用药信息标注提供参考。方法收集四川美康医药软件研究开发公司的合理用药信息支持系统收录的所有抗抑郁药品说明书,对孕妇及哺乳期妇女用药信息标注情况进行整理、统计、分析。结果本研究共收集到抗抑郁类药品说明书203份,其中,198份说明书有明确孕妇及哺乳期用药标识,占97.54%。妊娠期标识方面不够详实,63.63%仅给出简单的标识,而未给出具体的动物实验结果或人类数据。28.28%给出了监测内容的推荐,同时给出了少量的动物实验结果或人类意外暴露数据。仅8.08%用“风险总结/临床考虑/数据”来详细描述妊娠期的数据。哺乳期用药标识更为简单,超过70%的说明书仅根据可以通过乳汁分泌而建议停止哺乳。结论目前我国抗抑郁药品说明书中关于妊娠哺乳期用药的标识及推荐均较简单,进一步规范我国药品说明书中关于妊娠期用药的标识迫在眉睫,以保障妊娠哺乳期妇女用药安全。药师在咨询中若碰到药品说明书与循证证据有不一致时,需跟患者与医生充分做好沟通,权衡用药的利弊,选择对患者最优的方案。

Objective To provide reference for standardizing the labeling of medication information for pregnant and lactating women in the instructions of antidepressants drugs.Methods All the instructions of antidepressants included in the MCDEX system of Sichuan Meikang pharmaceutical software Co.,Ltd.were collected.The medication information labeling of pregnant and lactating women were sorted out,counted and analyzed.Results A total of 203 instructions of antidepressants were collected in this study,of which 198 instructions had clear drug labels for pregnant women and lactation,accounting for 97.54%.The identification of pregnancy was not detailed enough,63.63%only gave simple identification,but did not give specific animal experiment results or human data.28.28%gave recommendations on monitoring contents and gave a small number of animal experiment results or human accidental exposure data.Only 8.08%used"risk summary/clinical consideration/data"to describe the data of pregnancy in detail.It was even simpler in lactation identifications in instructions.More than 70%of the instructions suggested stopping lactation only based on the fact that it can be secreted through milk.Conclusion At present,the labeling and recommendation of drugs for pregnancy and lactation in the instructions of antidepressants in China are relatively simple.It is urgent to further standardize the labeling of drugs for pregnancy and lactation in the instructions of antidepressants in China.In case of any inconsistency between the drug instructions and evidence-based evidence during consultation,the pharmacist should fully communicate with the patient and the doctor,weigh the advantages and disadvantages of medication,and select the best scheme for the patient.