某院2014年在用药品说明书与非处方药说明书范本对比分析

发布时间：2018-04-29 02:17

本文选题：药品说明书 + 非处方药　；参考：《中国药房》2015年28期

【摘要】：目的:分析某院在用药品说明书与非处方药(OTC)说明书范本之间的差异,为加强说明书管理、减少临床用药的安全隐患提供参考。方法:将2014年某院1 324个在用药品与国家食品药品监督管理总局(CFDA)网站的OTC目录进行匹对。对属于OTC目录内的品种,比较其说明书与OTC说明书范本的差异,根据差异可能带来的用药风险程度可将其分为"可忽略""一般""重要"和"警惕"4个层次进行分析。结果:有244个在用品种属于OTC,其中32.38%的说明书与OTC说明书范本存在差异;差异可忽略、一般、重要和警惕4个风险层次比例分别为29.11%、34.18%、7.59%、29.11%。在重要风险层次中,"药物适应证限制"差异所占比例最大,为50.00%;在警惕风险层次中,"特殊疾病是否禁用"和"妊娠妇女是否禁用"差异分别占43.48%和39.13%。结论:说明书之间存在着重要用药信息缺失或不一致甚至表述相悖等问题。医院和各级管理部门需加强说明书规范化管理,保障临床安全、合理用药。
[Abstract]:Objective: to analyze the differences between OTC-based and OTC-based prescriptions in a hospital so as to provide a reference for strengthening the management of prescriptions and reducing the hidden dangers of clinical drug use. Methods: the OTC catalogue of 1 324 active drugs and State Food and Drug Administration (SFDA) websites in a hospital in 2014 were matched. The differences between the specification of OTC catalogue and the model of OTC specification were compared. According to the degree of drug risk caused by the differences, the varieties could be divided into four levels: "negligible" and "general" and "important" and "alert". Results: 244 products belong to OTC, of which 32.38% of the specifications are different from the OTC standard, and the difference is negligible. In general, the proportion of the four risk levels of importance and vigilance is 29.1134.18 and 7.5929.11respectively. In the important risk level, the difference of "drug indication limitation" was the largest (50.00,43.48%) and 39.13% (39.13%) respectively. Conclusion: there are some problems such as lack of important drug information, inconsistency or even contradiction between instructions. Hospitals and management departments at all levels should strengthen standardized management of instructions to ensure clinical safety and rational use of drugs.
【作者单位】：广州中医药大学第一附属医院药学部;
【分类号】：R95

【参考文献】