某儿童医院门诊药品说明书辅料标注情况及潜在有害辅料风险控制建议  

Labeling of Excipients and Potentially Harmful Excipients in Outpatient Medicines of a Children′s Hospital:an Analysis and Risk Prevention Suggestions

作　　者：陈静 赵力澜 CHEN Jing;ZHAO Li-lan(Department of Pharmacy,Fujian Children′s Hospital,Fuzhou 350014,China;Department of Thoracic Surgery,Shengli Clinical Medical College of Fujian Medical University,Fuzhou 350001,China)

机构地区：[1]福建省儿童医院药剂科,福建福州350014 [2]福建省立医院胸外科,福建福州350001

出　　处：《海峡药学》2023年第9期99-104,共6页Strait Pharmaceutical Journal

基　　金：福建省自然科学基金(2022J01221732)。

摘　　要：目的了解某儿童医院门诊药品说明书中辅料以及10种潜在有害辅料的定量信息及风险提示的标注情况,为用药安全提供参考。方法收集本院门诊药品说明书,统计辅料标注情况。选择丙二醇、乙醇、聚山梨酯80、苯甲醇、对羟基苯甲酸酯类、苯扎氯铵、阿斯巴甜、山梨糖醇、苯甲酸和苯甲酸钠在内的10种潜在有害辅料,统计药品说明书中上述潜在有害辅料的定量信息及风险提示的标注情况。结果331份说明书中有170份(52.57%)明确标注辅料,其中涉及175个辅料品种,总共有105种(60.00%)被中国药典收入。41个药品(24.12%)中涉及了10种潜在有害辅料,说明书中潜在有害辅料定量信息和风险提示的标注率分别为11.86%和15.25%。结论儿科药品说明书中辅料标注不完整、潜在有害辅料的定量信息及风险提示缺乏的情况普遍存在。建议相关部门对说明书的辅料标注情况进行规范和监督,制药企业应及时完善相关辅料信息,协助医生和药师进行风险与受益评估,保证儿童用药安全。OBJECTIVE To investigate the labeling and risk information of the excipients and potentially harmful excipients(PHEs)in the outpatient medicine of a children′s hospital,and to provide risk prevention recommendation for drug safety.METHODS We collected outpatient medicine instruction and analyzed the labeling ratio of the excipients.Specifically,10 PHEs including propylene glycol,ethanol,polysorbate-80,benzyl alcohol,parabens,benzalkonium chloride,aspartame,sorbitol,benzoic acid and sodium benzoate were selected.The quantitative information of the above-mentioned PHEs and the labeling of risk warnings in the drug instructions were analyzed.RESULTS Among the 331 instructions,170(52.57%)clearly labeled excipients,in which 105(60.00%)were included in the Chinese Pharmacopoeia.41 drugs(24.12%)contained the 10 PHEs,of which the ratio of quantitative information and risk warning of PHEs were 11.86%and 15.25%,respectively.CONCLUSION Incomplete labeling of excipients and lacking of quantitative information and risk warnings of PHEs are common in pediatric drug.We suggest that the labeling of excipients should be standardized and supervised by relevant organizations.The pharmaceutical industries should also improve excipient labeling information in a timely manner,to help clinicians and pharmacists in assessing risks and benefits,and ensure the safety of pediatric medication.

关 键 词：药品说明书 辅料 儿童 用药安全 

分 类 号：R969.4[医药卫生—药理学]