基于药学服务的妊娠用药登记的建立和探索  

Construction and exploration of pregnancy registries for medicine based on pharmaceutical service

作　　者：张骁[1] 叶淑雅 郑彩虹[1] Zhang Xiao;Ye Shuya;Zheng Caihong(Department of Pharmacy,Women′s Hospital,School of Medicine,Zhejiang University,Hangzhou 310006,China)

机构地区：[1]浙江大学医学院附属妇产科医院药剂科,杭州310006

出　　处：《中华医院管理杂志》2021年第3期241-244,共4页Chinese Journal of Hospital Administration

摘　　要：妊娠用药登记是药品上市后进行妊娠期用药风险评估的常用手段。作者介绍了浙江大学医学院附属妇产科医院基于药学服务的妊娠用药登记模式的探索与实践。以妊娠期药物咨询门诊为支点的妊娠用药登记,由药师团队同质化管理,按咨询问诊、药学指导、定期随访的信息化流程实施。药学人员在咨询门诊及随访工作中通过咨询者自主报告、药学人员问询和病例采样三大数据源建立咨询者药历;设计并构建信息筛选系统,将咨询药历按特定药物的妊娠期暴露归类;选择需求量较大的咨询药物,设计符合妊娠期用药特色的前瞻性研究方法,以特定药物妊娠期暴露与子代出生缺陷的相关性为研究主题开展妊娠用药登记研究。依托药学服务规范化、精细化、信息化管理水平的不断提升,今后将加强多中心合作,对妊娠药物暴露登记及其随访体系进行持续性研究与探索。The pregnancy registry for medicine is a common method for risk evaluation for drug safety evaluation during pregnancy.The authors introduced the exploration and practice of the pregnancy drug registry mode based on pharmacy service in Women′s Hospital School of Medicine Zhejiang University.The registry of pregnancy medication with the drug consultation clinic as the fulcrum was managed by the pharmacist team in a homogenization way,and implemented according to the information process of consultation,pharmacy guidance and regular follow-up.In the consultation and follow-up work,the pharmacists established the consultation drug history through three data sources:independent report of the consultant,inquiry of pharmaceutical personnel and case sampling.The pharmacists designed and constructed information screening system,classified the consultation medicine history according to the pregnancy exposure of specific drugs.The prospective research method was designed to meet the characteristics of pregnancy medication.The study was carried out on the relationship between pregnancy exposure and birth defects of offspring.Relying on the improvement of standardization,refinement and information management level of pharmaceutical services,multi center cooperation will be strengthened in the future to carry out continuous research on pregnancy drug exposure registry and follow-up system.

关 键 词：妊娠 药学服务 妊娠用药登记 药物安全性评估 

分 类 号：R95[医药卫生—药学]