我国儿童用药安全问题分析及政策建议

Analysis and Policy Suggestions about the Security Problems of Pediatric Medication in China

目的:为推动儿童用药临床试验发展及解决儿童用药安全问题提出建议。方法:通过文献分析法和网络调研法,了解我国儿童用药的现状,分析儿童用药安全存在的问题及原因,了解国外儿童用药发展经验,并提出相关的政策建议。结果与结论:我国儿童用药市场需求大但临床应用存在安全隐患,临床试验开展困难,管理法规缺失,上市后药品监测与评价不足。应建立激励机制,鼓励儿童临床研究;加强专业指导,促进儿童临床研究;开展多渠道研究,拓展儿童用药范围;强化上市后药品监测与评价,确保儿童用药安全等。

OBJECTIVE：To put forward reasonable suggestions to promote the development of clinical trials and security of pediatric medication.METHODS：The situation of pediatric medication in China was investigated by literature analysis and network investigation.The problems and causes for the security of pediatric medication were analyzed,and foreign experience was investigated in order to put forward some reasonable suggestions.RESULTS CONCLUSIONS：Pediatric medication is in urgent need but has risk factors,and it is difficulty to develop clinical trial while laws and regulations of management are absent.Medicine monitoring and evaluation are not enough after listing.We should set up motivation mechanisms,and encourage clinical study;conduct expert guidance,and promote clinical study;develop multi-channel research and expand the range of pediatric medication;strengthen post-marketing evaluation and surveillance and guarantee the safety of pediatric medication,etc.