基于电子病历系统创建妊娠期用药风险评估系统的实践与问题探讨

Practice and Discussion on Establishment of Risk Assessment System for Drug Use during Pregnancy Based on Electronic Medical Record System

母体及胚胎的健康与妊娠期用药存在相关性,但目前说明书所提供的妊娠期用药风险因果关系的人类资料极少。因涉及特殊人群的安全和伦理方面等因素,临床试验极少有孕妇参与,大部分仅参考临床前实验结果,所以进行流行病学在孕期特殊人群中上市后药物研究,已成为一个迫在眉睫的问题。本文基于电子病历系统创建妊娠期用药风险评估系统,使孕妇获取妊娠期用药风险评估和专业用药指导;通过工作平台对孕妇进行产后跟踪随访;妊娠期用药咨询的孕妇全程化管理,会对用药安全性研究起到积极的促进作用。

There is a correlation between maternal and embryo health and medication during pregnancy,but there are few human data on the causal relationship between medication risks during pregnancy provided in the current instructions.Because of the safety and ethics of special population,few pregnant women participate in clinical trials,and most of them only refer to the results of preclinical experiments.Therefore,it has become an urgent problem to conduct epidemiological research on post-marketing drugs among special population during pregnancy.Based on the electronic medical record system,this paper established a pregnancy medication risk assessment system to enable pregnant women to obtain pregnancy medication risk assessment and professional medication guidance.Follow-up of pregnant women after delivery was conducted through the work platform.The whole-process management of pregnant women during pregnancy medication consultation played a positive role in promoting the study of medication safety.