某院门诊药房中成药说明书儿童用药及药物相互作用标注情况分析

Analysis of labeling of children’s medication and drug interaction in Chinese patent medicine instructions in outpatient pharmacy of our hospital

目的统计分析门诊西药房中成药说明书中儿童用药及药物相互作用的标注情况,并提出建议。方法收集门诊药房目前在用的中成药药品说明书58份,对药品说明书中儿童用药、儿童注意事项、儿童用法用量及药物相互作用的标注情况进行统计,并按口服、外用,针剂等内容进行汇总分析。结果58份药品说明书中,口服药品50种,外用药品6种,针剂药品2种。口服药品儿童用药、儿童注意事项、儿童用法用量(包括小儿酌减)、药物相互作用标注率分别为14.00%、46.00%、22.00%、34.00%,外用药品标注率分别为33.33%、33.33%、0.00%、16.67%,针剂药品标注率分别为50.00%、50.00%、0.00%、0.00%。有明确的儿童用法用量的11份(包括小儿酌减)(18.96%);用法用量涉及儿童的有7份(12.07%),提醒儿童在医师/成人监护下使用的有12份(20.69%);儿童用药尚不明确、儿童用药安全性尚未确立的有9份(15.51%);提示儿童慎用、禁用的有1份(1.72%);未涉标注儿童用药说明的有32份(55.17%);提醒将药品放在儿童不能接触的地方的有22份(37.93%);未标注儿童注意事项的21份(63.79%)。结论中成药说明书中儿童用法用量标注率低、药物相互作用及禁忌缺失情况严重、儿童用药项标注的内容前后不一致导致患者不易合理使用。建议详细标注儿童用药内容、药物相互作用及禁忌、规范药品说明书的修订,提高中成药说明书的安全性、有效性和指导性,保障儿童安全合理用药。

Objective Statistical analysis of the labeling of children’s drug use and drug interaction in the instructions of Chinese patent medicines in the outpatient pharmacy of our hospital,and make recommendations.Methods Fifty-eight Specifications of Chinese patent medicines currently in use in the outpatient pharmacy of our hospital were collected.The labeling of children’s medication,precautions for children,dosage and drug interaction in drug instructions were counted.And according to oral,topical,injection and other contents of the summary analysis.Results Of the 58 drug instructions,50 were taken orally,6 were for external use and 2 were for injection.The labeling rates of oral drugs for children,precautions for children,dosage for children(including children’s discretion)and drug interaction were 14.00%,46.00%,22.00%and 34.00%respectively.The labeling rates of drugs for external use were 33.33%,33.33%,0.00%and 16.67%respectively.The labeling rates of injectable drugs were 50.00%,50.00%,0.00%,0.00%.There were 11(18.96%)with definite dosage for children’s use.Usage:7(12.07%)were related to children.Children were reminded to use them under the supervision of doctors/adults in 12 cases(20.69%).Nine(15.51%)of the children’s drug use were not clear and their safety had not yet been established.One of them(1.72%)suggested that children should be cautious and forbidden to use.32(55.17%)did not include any indication of medication for children.22(37.93%)were kept out of reach of children.21(63.79%)without a notice to children.Conclusion The low labeling rate of children’s usage and dosage in the instructions of Chinese patent medicines in our hospital,the lack of drug interaction and contraindication,the unclear content of the label of children’s medication makes it difficult for patients to understand.It is suggested that the contents of children’s medication,drug interactions and taboos should be marked in detail,and the revision of drug instructions should be standardized to improve the safety,effectiveness and guidance of Chinese patent medicine instructions,so as to ensure the safe and rational drug use in children.