药品说明书中儿童用药的标注分析

Labeling of children's medication in commonly used pediatric drug manuals

目的调查常用儿童药品说明书中儿童用药标注情况,分析其存在的问题,为规范临床儿童合理用药提供参考。方法对2022年1月至12月广东省妇幼保健院儿科常用的269份药品说明书中有关儿童用药部分进行统计学分析,并分别按照基药类型、剂型、国产与涉外对儿童用药标注情况进行对比。采用χ^(2)检验。结果常用药品说明书中儿童用药完整标注率仅为42.00%(113/269)。药品说明书中标注儿童用药信息基药有144份,其中儿童用药信息完整有53份(36.81%);非基药有125份,完整标注儿童用药信息有60份(48.00%);基药在儿童用药注意事项上与非基药之间比较差异有统计学意义(χ^(2)=6.371,P=0.012)。不同给药剂型中,口服剂最高,有144份,其中完整儿童用药信息有57份(39.58%);注射剂有71份,其中完整儿童用药信息有42份(59.15%);外用剂有46份,其中完整儿童用药信息有6份(13.04%);吸入剂仅有8份,未达统计学分析要求,不进行统计分析。对剩余3种(注射剂、口服剂、外用剂)剂型进行比较,结果表明用药剂量、完整的用药信息、缺标率(既无剂量又无儿童注意事项的描述)在各剂型间比较,差异均有统计学意义(χ^(2)=12.240、24.740、26.249,均P<0.05);注意事项在各剂型间差异无统计学意义(P>0.05)。在国内药品和涉及外资企业的药品中,其中国产药品有217份,完整的用药信息78份,标注率为35.94%;涉外药品有52份,完整的用药信息35份,标注率为67.31%。国产药品在注意事项上比涉外药品高,用药信息完整程度上比涉外药品低,差异均有统计学意义(χ^(2)=4.276、16.937,均P<0.05);国产药品缺标率高达24.42%。结论本院常用儿童药品说明书中儿童用药项标注率偏低,导致临床儿科超说明书用法普遍,应完善基药、外用剂和国产药品等儿童用药说明。

Objective To investigate the labeling of children's medication in commonly used pediatric drug manuals,analyze the existing problems,and provide reference for standardizing the rational use of medication in clinical pediatrics.Methods Statistical analysis was made on the part of children's medication in the instructions of 269 kinds of drugs commonly used in Department of Pediatrics,Guangdong Maternal and Child Health Hospital,and the labeling of children's medication was compared according to the type of basic drugs,dosage forms,and domestic and foreign drugs.χ^(2) test was used.Results The complete labeling rate of children's drugs in the instructions of commonly used drugs in our hospital was only 42.00%(113/269),including 36.81%(53/144)of basic drugs and 48.00%(60/125)of non-basic drugs,39.58%(57/144)of oral drugs,59.15%(42/71)of injectable drugs,and 13.04%(6/46)of topical drugs,35.94%(78/217)of domestic drugs and 67.31%(35/52)of foreign-related drugs.There was a statistically significant difference in the children's medication precautions between basic drugs and non-basic drugs(χ^(2)=6.371,P=0.012).The remaining 3 dosage forms(injectable,oral,and topical drugs)were compared.The results showed that there were statistically significant differences in the dosage,complete medication information,and lack of labeling rate(no dose and no description of children's precautions)among the 3 dosage forms(χ^(2)=12.240,24.740,and 26.249;all P<0.05).There was no statistically significant difference in the children's medication precautions among the 3 dosage forms(P>0.05).Domestic drugs had higher children's medication precautions than foreign-related drugs,and the completeness of drug use information was lower than that of foreign-related drugs,with statistically significant differences(χ^(2)=4.276 and 16.937,both P<0.05).The lack of labeling of domestic drugs was as high as 24.42%.Conclusions At present,the labeling rate of children's drug items in the clinical children's drug instructions in our hospital is low,which leads to the common off-label use in clinical pediatrics.The children's drug instructions of basic drugs,external agents,and domestic drugs should be improved.