药品说明书特殊人群项用药信息缺失情况调查分析

Investigation and Analysis of Deficiency Information Use in Specific Populations in Package Inserts

目的调查药品说明书特殊人群用药信息缺失情况,为药品监管、生产、使用部门提供参考。方法应用新编临床用药参考软件,在药品说明书"孕妇及哺乳期妇女用药"、"儿童用药"、"老年患者用药"项输入用药信息缺失有关的词句检索并统计结果。结果药品说明书特殊人群用药项各种检索词中最高用药信息缺失率分别为54.40%、32.36%、25.51%。口服制剂、注射剂最高用药信息缺失率分别为43.18%、28.64%。国家基本药物中最高用药信息缺失率为12.22%。结论药品监管、生产、使用单位应高度重视特殊人群用药信息缺失可能引发的风险,应采取提高药品注册标准、立法规范药品说明书等措施确保安全合理用药。

Objective To investigate and analyze deficiency information use in specific populations in package insert in order to provide reference to supervisory management department,manufacture enterprises and hospitals.Methods The software new edition clinical medication reference was utilized to search deficiency information on pregnant and lactation woman,children and senile patient using related words.Results The maximum deficiency information percentage of all retrieving words was 54.40%,32.36% and 25.51% for specific populations,for oral preparations,injection preparations and national essential drugs,the percentage was 43.18%,28.64% and 12.22%.Conclusion Deficiency information of specific populations should be paid more attention to avoid drug using risk,at the same time,effective measure should be adopted to ensure rational use of drug.