抗心律失常药品说明书中孕妇及哺乳期妇女用药信息标注情况统计分析
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篇名: 抗心律失常药品说明书中孕妇及哺乳期妇女用药信息标注情况统计分析
TITLE: Statistical analysis of medication information labeling of pregnant women and lactating women in the instructions of antiarrhythmic drugs
摘要: 目的 为规范抗心律失常药品说明书中孕妇及哺乳期妇女用药信息标注提供参考。方法收集医脉通科技有限公司官方网站“用药参考”项下收录的所有抗心律失常药品说明书,参照国家食品药品监督管理局发布的《化学药品和治疗用生物制品说明书规范细则》的规定,对孕妇及哺乳期妇女用药信息标注情况进行整理、统计、分析。结果本研究共收集到的111份抗心律失常药品说明书中,102份药品说明书有“孕妇用药”项标注(占91.89%),其中有用药指导意见、无用药指导意见的比例分别为75.68%、16.22%;88份药品说明书有“哺乳期妇女用药”项标注(占79.28%),其中有用药指导意见、无用药指导意见的比例分别为70.27%、9.01%。不同分类抗心律失常药中,“孕妇用药”项标注情况最佳为Ⅰ类抗心律失常药(占100%),而Ⅲ类标注(占25.00%)缺失最多“;哺乳期妇女用药”项标注情况最佳为Ⅳ类抗心律失常药(占94.44%),而Ⅰ类标注(占26.47%)缺失最多。部分同品种不同生产厂家药品说明书的“孕妇用药”及“哺乳期妇女用药”项标注内容存在差异。99份国内药企药品说明书中,92份(92.93%)单独列出“孕妇用药”及“哺乳期妇女用药”项,有用药指导意见的比例分别为74.75%、69.70%;12份国外药企药品说明书中,10份(83.33%)单独列出“孕妇用药”及“哺乳期妇女用药”项,有用药指导意见的比例分别为83.33%、75.00%。结论国内抗心律失常药品说明书标注内容存在“孕妇用药”及“哺乳期妇女用药”相关信息缺失、指导意见表述混乱、同品种不同生产厂家药品说明书标注内容不一致、修改更新滞后、说明书规范性欠佳等问题,应引起药品监督管理部门、药品生产企业的重视,并不断加强对说明书的管理和规范。
ABSTRACT: OBJECTIVE To provide reference for standardizing the labeling of medication information for pregnant women and lactating women in the instructions of antiarrhythmic drugs. METHODS The instructions of antiarrhythmic drugs were collected from the terms of “medication reference ”on official website of Yimaitong Technology Co. ,Ltd. The labeling of medication information of pregnant women and lactating women were sorted out ,counted and analyzed with reference to the Detailed Rules for Specifications of Instructions of Chemical Drugs and Therapeutic Biological Products issued by the State Food and Drug Administration. RESULTS A total of 111 instructions of antiarrhythmic drugs were collected in this study ,of which 102 instructions were marked with “medication for pregnant women ”(91.89%),of which the proportion of those with medication guidance and without medication guidance were 75.68% and 16.22% respectively. Eighty-eight drug instructions were marked with the item “medication for lactating women ”(79.28%),of which the proportion of those with medication guidance and without medication guidance were 70.27% and 9.01% respectively. Among different categories of antiarrhythmic drugs ,the best labeling of “medication for pregnant women ”was class Ⅰ antiarrhythmic drugs (100%),while class Ⅲ drugs(25.00%)were most missing ; class Ⅳ antiarrhythmic drugs (94.44%)were the best labeled for “medication for lactating women ”,while class Ⅰ(26.47%)were the most missing . There were differences in the labeling contents of “medication for pregnant women ”and“medication for lactating women ”in some drug instructions of the same variety from different manufacturers. Among the 99 drug instructions of domestic pharmaceutical enterprises , 92 listed the items of “medication for pregnant women”and“medication for lactating women ”,and the proportions of them with medication guidance were 74.75% and 69.70% respectively;among the 12 drug instructions of foreign pharmaceutical enterprises ,10(83.33%)listed the items of “medication for pregnant women ”and“medication for lactating women ”,and the proportion with medication guidance was 83.33% and 75.00% respectively. CONCLUSIONS There are some problems in the labeling content of domestic antiarrhythmic drug instructions,such as the lack of information related to “medication for pregnant women ”and“medication for lactating women ”, the confusion of guidance expression , the inconsistent content of drug instructions of the same variety from different manufacturers,the lag of modification and update ,and the poor standardization of drug instructions. Drug supervision and administration departments and drug manufacturers should pay attention to them and constantly strengthen the management and standardization of instructions.
期刊: 2022年第33卷第09期
作者: 李云娇,黄汉辉,严鹏科
AUTHORS: LI Yunjiao ,HUANG Hanhui ,YAN Pengke
关键字: 孕妇;哺乳期妇女;抗心律失常药;药品说明书;特殊人群用药
KEYWORDS: pregnant women ;lactating women ;antiarrhythmic drugs ;drug instructions ;medication for special population
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