中药注射剂药品说明书标注不规范所致不合理用药调查分析

Investigation and Analysis of Unreasonable Drug Use Caused by Non-Standard Instrcutions of Traditional Chinese Medicine Injection

目的了解中药注射剂药品说明书标注不规范对临床不合理用药的影响。方法整理右江民族医学院附属医院常用中药注射剂药品说明书30份,分析内容标注存在的问题,并设计问卷,调查医师、护士、药师对中药注射剂药品说明书不规范、药品不良反应(ADR)及临床不合理用药的认知情况。结果30份药品说明书主要项目齐全,但药物相互作用、药理学、药代动力学及特殊人群用药部分标注率较低,内容很少且过于简略;仅29.63%的医师、11.25%的护士、18.10%的药师在使用中药注射剂前熟悉具体成分;35.19%的医师认为中药注射剂说明书并未注明严格的滴速,20.83%的护士认为工作太忙,没时间观察中药注射剂引起的ADR;仅50.00%的医师、31.25%的护士、21.90%的药师仔细阅读过中药注射剂的说明书;76.19%的药师、62.96%的医师、31.67%的护士遇到过说明书标示"尚不明确"的情况;医务人员认为中药注射剂说明书药品不良反应(64.16%)、特殊人群用药(61.90%)、相互作用(52.88%)项表述模糊。结论中药注射剂药品说明书内容标注不规范,易引起医务人员用药困惑或仅凭个人经验用药,是造成临床不合理用药的重要原因。

Objective To understand the influence of non-standard labels of traditional Chinese medicine(TCM)injection on clinical irrational use of drugs.Methods A total of 30 copies of the TCM injections commonly used in the Affiliated Hospital of Youjiang Medical College for Nationalities were sorted out.The existing problems in the contents and labels were analyzed,and questionnaires were designed to investigate the doctors,nurses,and pharmacists on the irregularities of TCM injections,as well as the cognitive situation of adverse drug reactions(ADR)and clinical irrational use.Results The main items of the 30 TCM injections were complete,but the labeling rate of drug interaction,pharmacology,pharmacokinetics,and special population medication was low,and the content was quite few and too brief;only 29.63%of physicians,11.25%of nurses,18.10%of pharmacists were familiar with the specific ingredients before using TCM injections;35.19%of physicians thought that the instructions for TCM injections did not indicate a strict drip rate;20.83%of the nurses thought that their work was too busy to observe the adverse drug reactions caused by TCM injections;only50.00%of physicians,31.25%of nurses,21.90%of pharmacists had carefully read the instructions of TCM injections;76.19%of pharmacists,62.96%of physicians,31.67%of nurses had encountered the situation where the instructions were marked as″unclear″;the medical staff thought that the description of TCM injection instructions was vague in adverse drug reactions(64.16%),special populations(61.90%),and interactions(52.88%).Conclusion The contents of the instruction of TCM injections are not standardized,which can easily cause confusion among medical staff or use drugs based on personal experience,and is an important reason for clinical irrational use of drugs.