摘要
目的促进我国药品说明书孕妇及哺乳期妇女用药内容的完善与规范,保障孕妇及哺乳期妇女用药安全有效。方法通过文献分析的方法,总结目前我国药品说明书中孕妇及哺乳期妇女用药标示存在的问题并进行原因分析,提出相应的风险控制建议。结果目前我国部分药品说明书孕妇及哺乳期妇女用药内容存在标示不足或不明确现象,此与孕妇及哺乳期妇女用药研究及企业责任意识不足等因素相关。结论在加强孕妇及哺乳期妇女用药的研究与评价、强化企业责任意识的同时,建议业界制定相应的权威指南与说明书规范用语,并加强对说明书的监管,促进药品说明书中孕妇及哺乳期妇女用药信息的完善与规范,增强对用药人群的指导性。
Objective To promote the improvement and standardization of labeling contents of medicines used for pregnant and lactating women on package inserts in China, and to ensure the safety and effectiveness of medicines used for pregnant and lactating women. Methods By means of literature analysis, the problems existing on labeling contents of medicines used for pregnant and lactating women in package inserts in China were comprehensively summarized, then their causes were analyzed and the appropriate risk control recommendations were proposed. Results The labeling contents of medicines used for pregnant and lactating women in some package inserts were insufficient or imprecise in our country in present,which may be related to more factors, such as insufficient studies of medication for pregnant and lactating women, lack of the sense of responsibility of enterprises, etc. Conclusion Studies and evaluation of medicines used for pregnant and lactating women and the sense of responsibility of enterprises need to be further strengthened. Meanwhile, appropriate authoritative guidelines and standard terms about label and package inserts contents should be recommended to establish, the supervision of the label and package inserts also need to be strengthened. All of these will promote the improvement and standardization of the label and package inserts medication information used for pregnant and lactating women as far as possible, which also enhance medication guidance on this target population.
出处
《中国药物警戒》
2015年第4期211-218,共8页
Chinese Journal of Pharmacovigilance
关键词
药品说明书
孕妇
哺乳期
用药
标示问题
风险控制
建议
package insert
pregnant woman
lactation
medication
labeling problems
risk control
recommendations
作者简介
夏东胜，女，主任药师，药品上市后技术评价：
