| 儿科超说明书用药现状与对策分析 |
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| 引用本文： | 吴文文,王珊珊,李曼,季兴,倪明明,陈峰,许静.儿科超说明书用药现状与对策分析[J].药物流行病学杂志,2019(6):418-422. |
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| 作者姓名： | 吴文文 王珊珊 李曼 季兴 倪明明 陈峰 许静 |
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| 作者单位： | 南京医科大学附属儿童医院药学部 南京 210008 |
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| 摘 要： | 摘 要通过归纳总结国内外儿科超说明书用药现状、原因及管理政策，提出规范我国儿科超说明书用药的对策。目前，世界发达国家基本上都对药品超说明书使用进行立法或实行相应政策，而我国对超说明书用药尚缺乏国家层面上的统一管理。儿科超说明书用药风险高，我国应针对超说明书用药原因，借鉴发达国家的管理方式，通过制定使用原则、分级管理、鼓励临床试验完善说明书信息等政策，降低儿科超说书用药风险，保障儿童用药安全。
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| 关 键 词： | 儿科 超说明书用药 儿童用药 合理用药 |
Off label Use of Medicine in Pediatric Patients: Current Status and Future Directions |
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| Wu Wenwen,Wang Shanshan,Li Man,Ji Xing,Ni Mingming,Chen Feng,Xu Jing.Off label Use of Medicine in Pediatric Patients: Current Status and Future Directions[J].Chinese Journal of Pharmacoepidemiology,2019(6):418-422. |
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| Authors: | Wu Wenwen Wang Shanshan Li Man Ji Xing Ni Mingming Chen Feng Xu Jing |
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| Abstract: | ABSTRACTThe current situation of off label utilization in children and factors associated with this issue were analyzed and summarized via studying published literatures around the world including research papers, systemic reviews, legal frameworks and regulation documents. At present, most developed countries in the world have legislated or implemented corresponding policies for off label uses of medicines to ensure the safety and effectiveness of off label prescribing in pediatric patients,there is no unified regulation for the off label uses medicines in children from the national level of Chinese government. There is relatively higher risk of adverse events with off label prescribing in pediatric patients. We should better understand the factors associated with the off label uses and learn from the developed countries for their regulatory strategies. Through adding prerequisites for off label use, hierarchical management, and encouraging more clinically relevant medical research, it will reduce inappropriate use, enhance patient safety and effectiveness. |
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| Keywords: | Pediatrics Off label use Pediatric medicines Rational drug use |
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