203份静脉滴注药品说明书用药信息标注情况分析

Analysis of Labeling of Medication Information in 203 Intravenous Drug Manuals

目的提高静脉滴注治疗的安全性和有效性。方法收集医院2020年12月的203份静脉滴注药品说明书,对其中溶剂、滴注浓度与滴速的标注情况和药物种类、代表药物进行统计与分析。结果203份药品说明书中,181份明确标注了溶剂(89.16%),其中消化系统药物、呼吸系统药物、中药注射剂和心血管系统药物等的标注比例较高;近50%的药物可用0.9%氯化钠注射液和5%葡萄糖注射液作溶剂,部分药物对溶解和稀释所用溶剂的要求不同。90份明确标注了滴注浓度(44.33%),其中消化系统药物和抗微生物药物等的标注比例相对较高。另有11份中药注射剂虽明确标注了用法用量,但有效成分信息不明确,无法计算滴注浓度。69份明确标注了滴速(33.99%),其中标注比例相对较高的药物种类包括中药注射剂和抗微生物药物,另有50份只标注了输液时间,或仅注明应严格控制滴速、滴速不宜过快或需缓慢滴注等。有2份(0.99%)标注内容前后矛盾。结论203份静脉滴注药品说明书中,溶剂标注率较高,但严重缺乏滴注浓度与滴速的标注,无法满足临床合理使用需求。对于药品说明书中明确标注溶剂、滴注浓度与滴速的静脉滴注药品,临床应严格按其规范使用。同时,药品监管部门应加强对药品说明书的规范管理,要求生产厂家准确标注相关信息。

Objective To improve the safety and effectiveness of intravenous drip therapy.Methods A total of 203 intravenous drug manuals in our hospital were collected,and the labeling information of solvent,infusion concentration and infusion speed,the types of drug and representative drugs were statistically analyzed.Results A total of 181(89.16%)drug manuals of clearly labeled solvents were found in 203 intravenous drug manuals,among which the labeling proportion of digestive system drugs,respiratory system drugs,traditional Chinese medicine(TCM)injections and cardiovascular system drugs was relatively high.0.9%Sodium Chloride Injection and5%Glucose Injection could be used as solvents for nearly 50%of drugs.Some drugs had different requirements for solvents for dissolution and dilution.The infusion concentration was clearly labeled in 90(44.33%)drug manuals,of which the labeling proportion of digestive system drugs and antimicrobial drugs was relatively high.Although the usage and dosage of 11 TCM injections were clearly labeled,the information of active ingredients was not clear,so the infusion concentration could not be calculated.The infusion speed was clearly labeled in 69(33.99%)drug manuals,of which the drug types with relatively high labeling proportion included TCM injections and antimicrobial drugs,and the other 50 drug manuals only labeled the infusion time,or only indicated that the infusion speed should be strictly controlled,the infusion speed should not be too fast or slow,etc.The labeling information of two(0.99%)drug manuals was inconsistent.Conclusion The labeling rate of solvent is relatively high in 203 intravenous drug manuals,but the labeling rate of infusion concentration and infusion speed is seriously lacking,which can not meet the requirements of clinical rational use.Intravenous drugs with clearly labeled solvent,infusion concentration and infusion speed in the drug manual should be used strictly according to their specifications in the clinical.Meanwhile,the drug administration should strengthen the standardized management of drug manuals and require drug manufacturers to accurately label relevant information in the intravenous drug manuals.