中国药物警戒
中國藥物警戒
중국약물경계
CHINESE JOURNAL OF PHARMACOVIGILANCE
2015年
4期
211-218
,共8页
药品说明书%孕妇%哺乳期%用药%标示问题%风险控制%建议
藥品說明書%孕婦%哺乳期%用藥%標示問題%風險控製%建議
약품설명서%잉부%포유기%용약%표시문제%풍험공제%건의
package insert%pregnant woman%lactation%medication%labeling problems%risk control%recommendations
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。
目的：促進我國藥品說明書孕婦及哺乳期婦女用藥內容的完善與規範，保障孕婦及哺乳期婦女用藥安全有效。方法通過文獻分析的方法，總結目前我國藥品說明書中孕婦及哺乳期婦女用藥標示存在的問題併進行原因分析，提齣相應的風險控製建議。結果目前我國部分藥品說明書孕婦及哺乳期婦女用藥內容存在標示不足或不明確現象，此與孕婦及哺乳期婦女用藥研究及企業責任意識不足等因素相關。結論在加彊孕婦及哺乳期婦女用藥的研究與評價、彊化企業責任意識的同時，建議業界製定相應的權威指南與說明書規範用語，併加彊對說明書的鑑管，促進藥品說明書中孕婦及哺乳期婦女用藥信息的完善與規範，增彊對用藥人群的指導性。
목적：촉진아국약품설명서잉부급포유기부녀용약내용적완선여규범，보장잉부급포유기부녀용약안전유효。방법통과문헌분석적방법，총결목전아국약품설명서중잉부급포유기부녀용약표시존재적문제병진행원인분석，제출상응적풍험공제건의。결과목전아국부분약품설명서잉부급포유기부녀용약내용존재표시불족혹불명학현상，차여잉부급포유기부녀용약연구급기업책임의식불족등인소상관。결론재가강잉부급포유기부녀용약적연구여평개、강화기업책임의식적동시，건의업계제정상응적권위지남여설명서규범용어，병가강대설명서적감관，촉진약품설명서중잉부급포유기부녀용약신식적완선여규범，증강대용약인군적지도성。
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.
