146份高警示药品说明书中特殊人群用药信息标注情况调查  

Investigation on Information Annotation of Special Populations in 146 Instructions of High-Alert Drugs

作　　者：刘鑫[1] 刘雅娟[1] Liu Xin;Liu Yajuan(The First Hospital of Jilin University,Changchun 130021,China)

机构地区：[1]吉林大学第一医院,长春130021

出　　处：《儿科药学杂志》2022年第2期30-33,共4页Journal of Pediatric Pharmacy

摘　　要：目的:调查高警示药品说明书中对孕妇及哺乳期妇女、儿童、老年人等特殊人群的信息标注情况,为特殊人群合理用药提供参考。方法:根据我院高警示药品目录,收集我院有使用记录的高警示药品说明书146份,对说明书中孕妇及哺乳期妇女、儿童、老年人等特殊人群用药标注信息进行统计分析。结果:146份高警示药品说明书中,儿童标注信息情况在A、B、C三级高警示药品中均为最低。除"特殊人群用药"项,儿童用药标注最高为"用法用量",占24.66%;妊娠及哺乳期用药标注最高为"禁忌证",分别为39.04%和29.45%;老年用药标注最高为"注意事项",占15.75%。四类人群未标注情况哺乳期人群占比最高为10.27%。结论:高警示药品说明书的标注信息需进一步完善,国家应从法律层面制定相应的法律法规进行约束,药品生产企业应完善临床试验,补充说明书中特殊人群高警示药品数据及标注。临床药师应对特殊人群使用高警示药品给予特殊的用药指导,规避药品不良反应的发生。Objective: To investigate the information annotation of special populations such as pregnant women, lactating women, children and the elderly in the instructions of high-alert drugs, so as to provide reference for rational drug use in special populations. Methods: According to the catalogue of high-alert drugs in our hospital, 146 instructions of high-alert drugs with use records were collected, and information annotation of pregnant women, lactating women, children and the elderly in the instructions were statistically analyzed. Results: Among the 146 instructions of high-alert drugs, the information marked for children was the lowest among the level A, B and C high-alert drugs. Except for the item “medication for special populations”, the highest information annotation for children’s medication was “usage and dosage”, accounting for 24.66%. The highest information annotation for pregnant women and lactating women was “contraindication”, 39.04% and 29.45%, respectively. The highest information annotation for the elderly was “precautions”, accounting for 15.75%. Lactating women without information annotation took the lead(10.27%) of the four groups. Conclusion: The information annotation of high-alert drug instructions needs to be further improved, which requires the state to formulate relevant laws and regulations from the legal level. Drug manufacturers should improve the clinical trials and supplement the data and annotation of instructions of high-alert drugs for special populations. Clinical pharmacists should give special medication guidance to special populations with high-alert drugs to avoid the occurrence of adverse drug reactions.

关 键 词：高警示药品 说明书 特殊人群 孕妇 哺乳期 儿童 老年人 

分 类 号：R969.3[医药卫生—药理学]