某院呼吸科3种常用抗菌药物超说明书用药现状分析及干预策略

Analysis on Current Situation of Off-label Usage of 3 Kinds of Commonly Used Antibacterials in Respiratory Department of a Hospital and Their Intervention Strategy

目的:分析医院呼吸科常用抗菌药物超说明书用药现状,并探究其相关干预策略。方法:选取医院呼吸科住院患者(2020年1月-12月)1 068例病历资料,统计其抗菌药物超说明书用药以及各类抗菌药物超说明书的用药率、用药类型、给药途径等内容,根据国家食品药品监督管理总局(CFDA)发布的最新专家共识、指南与药品说明书要求,判断是否超说明用药;分析其超说明书用药类型、常用抗菌药物超说明书用药现状,以及不同职称资格的医师与不同性别、年龄患者的超说明书用药分布。结果:1 068张抗菌药物处方中,超说明书用药处方235张(占22.00%),其中超适应证、超用法用量处方数量占60.43%、28.09%;不同职称资格的医师以及不同性别、年龄患者超说明书用药的分布之间具有相关性(P<0.05);在常见抗菌药物的超说明书用药处方中,头孢呋辛和美罗培南的处方主要为超用法用量使用,而头孢噻肟的处方主要为超适应证使用。结论:呼吸科常用抗菌药物普遍存在超说明书用药,且多为超用法用量、超适应证用药;另外,中高职称资格医师开具超说明书用药更为普遍,常用于老年患者;因此,临床应规范抗菌药物的使用,并强化临床管理制度,完善相关法律法规,规范用药教育等措施,以降低超说明书用药风险,科学防治疾病。

Objective:To analyze the current status of off-label usage of common antibacterials in respiratory department of a hospital,and to explore the related intervention strategies.Methods:The medical records of 1068 inpatients in the respiratory department of the hospital(from January to December 2020)were selected to statistically analyze the offlabel usage of antibacterials and the rate,type and route of off-label usage of all kinds of antibacterials.Based on the latest version expert consensus approved by China Food and Drug Administration(CFDA),the guidelines and the requirements of the drug instructions,to judge whether the drug was used beyond the specification.The types of off-label drug usage,the current situation of off-label drug usage of commonly used antibacterials,and the distribution of off-label drug usage in physicians with different professional titles and qualifications and patients of different genders and ages were analyzed.Results:In the 1068 antibacterial prescriptions,235 prescriptions for off-label drug usage accounted for 22.00%,among which the number of prescriptions for over-indication and over-usage accounted for 60.43%and 28.09%.There was a correlation between the distribution of off-label drug in physicians with different professional titles and qualifications and patients of different genders and ages(P<0.05).Among the off-label prescriptions of common antibacterials,most those of cefuroxime and meropenem existed the situations of overdosage,while most those of cefotaxime existed the situations of use out of indication.Conclusion:The commonly used antibacterials in respiratory department were commonly used off-label,and most of them were used in excess of usage and dosage and indication.In addition,it was more common that the off-label prescriptions were given to elderly patients by qualified physicians with middle or senior professional title.Therefore,clinical usage of antibacterials should be standardized,clinical management system should be strengthened,relevant laws and regulations should be improved,drug education should be standardized and other measures should be taken to reduce the risk of off-label drug usage and to prevent and treat diseases scientifically.