《国家基本药物目录》(2012年版)药品儿童用药信息分析

目的:分析我国《国家基本药物目录》(2012年版)药品儿童用药信息情况,为进一步完善我国儿童用药政策提供相关建议。方法:收集最新版本的《国家基本药物目录》(2012年版)药品说明书,提取儿童用药信息,采用Excel 2007软件进行数据统计分析。结果:《国家基本药物目录》(2012年版)按展开剂型计算:37.08%有儿童用法用量,3.37%有新生儿用法用量,1.61%有早产儿用法用量,7.38%涉及儿童的药动学数据,10.59%禁用于各年龄段儿童。无儿童用法用量的药品按品种名称通过Micromedex数据库检索,37.73%的药品涵盖的全部给药途径均有儿童用法用量,4.19%的药品涵盖全部给药途径均有新生儿用法用量,3.59%有早产儿用法用量,19.76%涉及儿童药动学数据。结论:《国家基本药物目录》(2012年版)化学药品和生物制品中儿童用药信息仍较缺乏,儿童药动学数据很少。建议我国进一步完善儿童用药政策。

Analysis of information labeling pediatric medication in 2012 edition of National Essential Medicine List

OBJECTIVE OBJECTIVE To analyze 2012 edition of National Essential Medicine List for chemical medicines and biological products labeling information for pediatric medication,provide a suggestion of policy for children's medication.METHODS Package inserts of drugs in 2012 edition of National Essential Medicine List were used to analyze 309 chemical medicines and biological products for labeling information for pediatric medication,by using Excel 2007 software for data calculation and statistical analysis.RESULTS For extended dosage forms in 2012 edition of National Essential Medicine List,37.08% of all dosage forms were labeled with children's dosage,3.37% with newborn's dosage,1.61% with premature infant's dosage,7.38% with pediatric pharmacokinetic data,10.59% were forbidden in children of indifferent ages.Medicines involved in off-labeling with children's dosage were searched in a database named Micromedex,37.73% were labeled with children's dosage,4.19% with newborn's dosage,3.59% with premature infant's dosage,19.76% with pediatric pharmacokinetic data.CONCLUSION Pediatric information of drugs is still insufficient in 2012 edition of National Essential Medicine List for chemical and biological drugs,including pharmacokinetic data.It is suggested to further improve medical policy for pediatric medication in China.