全球儿童合理用药国家药物政策现状分析

发布时间：2018-08-25 16:01

【摘要】：目的:评价全球儿童合理用药国家药物政策现状及实施情况,为建立适合我国国情的儿童合理用药国家药物政策提供决策依据。方法:检索国内外相关数据库,查阅世界卫生组织(WHO)、欧盟以及多个国家和地区的药品管理相关网站,用预先设计的数据提取表收集儿童合理用药政策相关信息,并进行归纳、总结和分析。结果:最终纳入45篇文献,涉及WHO和欧盟、美国、加拿大、英国、爱尔兰、荷兰、德国、西班牙、法国、澳大利亚、新西兰、中国、印度、韩国、日本、南非等多个国家和地区。各国儿童合理用药国家药物政策共同关注的要点包括促进儿童药物临床试验的开展,制定和推广儿童基本药物目录,制定和推广国家儿童处方集、标准治疗指南等用药标准,促进儿童药物上市后的监测等4个方面。美国、欧盟和日本制定了儿童药物临床试验的国家法规政策,WHO、南非和印度制定了儿童基本药物目录,WHO、英国和我国制定了儿童处方集。结论:建议相关部门参考美国和欧盟等国家和地区的经验,建立适合我国儿童疾病负担和用药情况的国家药物政策。
[Abstract]:Objective: to evaluate the current situation and implementation of the national drug policy for children in the world, and to provide a decision basis for the establishment of a national drug policy for children with rational drug use. Methods: the relevant databases at home and abroad were searched, and the (WHO), European Union of the World Health Organization (WHO) and the drug management websites of many countries and regions were consulted, and the relevant information on the rational drug use policies of children was collected and summarized by pre-designed data extraction table. Summary and analysis Results: finally, 45 articles were included, covering WHO and EU, USA, Canada, UK, Ireland, Netherlands, Germany, Spain, France, Australia, New Zealand, China, India, Korea, Japan, South Africa and many other countries and regions. The key points of common concern in national drug policies for rational use of children in various countries include promoting clinical trials of children's drugs, developing and popularizing catalogues of essential drugs for children, developing and promoting national prescriptions for children, standard treatment guidelines, etc. To promote the monitoring of children's drugs after marketing. The United States, the European Union and Japan have formulated national regulations and policies for clinical trials of children's drugs, South Africa and India have formulated a catalogue of essential drugs for children, and the United Kingdom and China have formulated prescriptions for children. Conclusion: it is suggested that the relevant departments should refer to the experiences of countries and regions such as the United States and the European Union and establish a national drug policy suitable for the burden of disease and drug use among children in China.
【作者单位】：四川大学华西第二医院药学部;四川大学华西第二医院循证药学中心;出生缺陷与相关妇儿疾病教育部重点实验室;四川大学华西药学院;
【基金】：国家自然科学基金资助项目(No.81373381) 四川大学华西第二医院新芽科研基金(No.kx034)
【分类号】：R951

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