我国非处方药说明书范本中妊娠期和哺乳期女性用药信息调查分析  

Investigation and Analysis of Pregnancy and Lactation Medication Information in Non-prescription Drug Instruction Templates in China

作　　者：周呈瑞 李子君 魏凯 余爱荣 Zhou Chengrui;Li Zijun;Wei Kai;Yu Airong(Department of Pharmacology,General Hospital of Central Theater Command,Wuhan 430070,China;People’s Liberation Army 32709)

机构地区：[1]中国人民解放军中部战区总医院临床药理科,武汉430070 [2]中国人民解放军32709部队

出　　处：《药物流行病学杂志》2020年第1期35-38,共4页Chinese Journal of Pharmacoepidemiology

摘　　要：目的:评估国家药品监督管理局(NMPA)官网中非处方药说明书范本关于妊娠期和哺乳期女性用药信息标示的完整性和准确性。方法:收集截止到2018年11月11日NMPA官网中,非处方药化学药品说明书范本和非处方药中成药说明书范本,对范本的【禁忌】和【注意事项】中关于妊娠期和哺乳期女性用药信息标示情况进行统计分析。结果:我国非处方药说明书范本对妊娠期和哺乳期女性用药信息的标示情况仍存在较大空缺。非处方药化学药品说明书范本的用药信息标示率低于中成药(P<0.05),但其对妊娠期和哺乳期女性有指导意义的用药信息标示率明显高于中成药(P<0.01);对妊娠期女性有指导意义的用药信息标示率明显高于哺乳期女性(P<0.01)。结论:保障妊娠期和哺乳期女性用药的安全和有效,需要不断完善和规范说明书范本的用药信息,建立妊娠期和哺乳期女性用药信息数据库等措施。Objective:Assessing the completeness and accuracy of non-prescription drug instruction template information for the use in pregnancy and lactation in the National Medical Products Administration(NMPA) Drug Inquiry. Methods:Collecting all the non-prescription chemical drug instruction templates and Chinese patent medicine instruction templates as of 11 November 2018 from the NMPA website. Excluding the medicines since they were not meant to be used in pregnancy and lactation, medication information for pregnancy and lactation in the [contraindication] and [precaution] of the remaining 5 567 templates was used to do the statistical analysis. Results:The medication information deficits in Chinese non-prescription drug instruction templates for the use of pregnancy and lactation were both found in NMPA websites. According to the analysis, the rate of medication information marking in non-prescription drug instruction templates was lower than in Chinese patent medicine(P<0.05), and the marking rates in [contraindication] and [precaution] were both significantly lower than in Chinese patent medicine(P<0.01);In chemical drug instruction templates, the marking rates with effective guidance for pregnancy and lactation were significantly higher than in Chinese patent medicine(P<0.01), and the marking rate with effective guidance for pregnancy was also higher than the rate for lactation. Conclusion:Ensuring the safety and effectiveness of medication use for pregnancy and lactation needs to improve and standardize the medication information in instruction templates, establish the database of medication information for pregnancy and lactation and so on.

关 键 词：非处方药 药品说明书范本 妊娠 哺乳 合理用药 

分 类 号：R951[医药卫生—药学]