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

Abstract: 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.

Key words: package insert, pregnant woman, lactation, medication, labeling problems, risk control, recommendations