儿童多剂量包装口服药品启用后使用期限标注情况调查及分析

Investigation and Safety Analysis on Labeling of the Service Life after the Multi-Dose Packaged Oral Drugs Be Used for Children

目的:调查我院儿童多剂量包装口服药品分剂量使用情况及启用后使用期限标注情况,了解儿童多剂量包装口服药品启用后使用期限标注现状,为药品的质量与安全管理提供参考。方法:通过我院PASS临床药学管理系统抽取门诊处方,分析药品分剂量使用情况;根据我院药品供应目录,除外自制制剂,筛选出多剂量口服药品,查阅药品说明书中药品启用后使用期限的标注情况。结果:我院口服药品346种,多剂量包装口服药品218种。明确提到多剂量口服药品启用后使用期限的共8种(3.67%);在标注使用期限后详细说明贮存条件的共3种(1.38%);提及贮藏条件但未提及使用期限的1种(0.46%)。提及遮光或避光保存的共23种,提及遮光或避光保存且采用棕色或褐色包装的仅3种。结论:多剂量包装口服药品分剂量使用在儿童医院较为常见,多剂量包装口服药品说明书启用后使用期限标注率低,不同生产厂家的口服药品启用后的使用期限标注不统一,多剂量包装口服液体药品贮藏条件与贮藏容器不统一。儿童使用多剂量包装口服药启用药品后药品安全性不可保障,影响药物疗效及儿童用药安全。

Objective:To investigation the usage of multi-dose drugs and the labeling of the service life after the multi-dose packaged oral drugs be used for children in our hospital and understand its current situation,to provide references for the quality and safety management of drugs.Methods:Transfer the prescription of the outpatient department in our hospital through PASS PharmAssist;according to the drug supply list of our hospital,except for self-made preparations,multi-dose oral drugs were screened out,and the labeling of the service life after the usage of drugs in the drug instructions was consulted.Results:There were 346 kinds of oral drugs in our hospital,and 218 kinds of multi-dose packaged oral drugs.There were 8 kinds of drugs mentioned clearly of the service life after the drugs being used,accounting for 3.67% of the total;and 3 drugs with detailed storage conditions after labeling the service life,accounting for 1.38%,and one that mentioned storage conditions but did not mentioned service life,accounting for 0.46%.There were 23 species mentioned to be protected from light or dark,and only 3 species mentioned to be protected from light or dark and packed in brown.Conclusion:The multi-dose packaged oral drugs is commonly used in children’s hospital;The labeling rate of service life of multi-dose packaged oral drugs is low;the labeling of service life of oral drugs from different manufacturers is not uniform;the storage conditions and containers of multi-dose packaged oral liquid drugs are not uniform.The safety of children’s use of multi-dose packaged oral drugs cannot be guaranteed,which affects the efficacy and safety of children.