某院生殖医学中心门诊超说明书用药调查分析

Investigation and Analysis of Off-labeled Drug Use in Outpatient Clinic of Reproductive Medicine Center in a Hospital

目的:分析生殖医学中心门诊超说明书用药情况,为临床合理用药提供参考,并进一步规范临床超说明书用药行为。方法:采用回顾性调查法,抽取2018年1~12月生殖医学中心门诊处方中所有超说明书用药处方,根据药品说明书,对超说明书用药处方进行统计分析,查阅相关指南、文献等对其用药合理性进行分析评价。结果:超说明书用药类型包括超适应证用药、超剂量用药和超给药途径用药。黄体酮注射液、左卡尼汀口服液、雌二醇/雌二醇地屈孕酮片等均有相关国内外指南推荐,循证医学证据级别较高,其超说明书用药较合理;羟乙基淀粉200/0. 5氯化钠注射液、戊酸雌二醇片、辅酶Q10片等其有效等级有效性具有争议;硒酵母片、维生素E胶丸未见相关文献、指南、国内外权威医学专著等报道,属于经验用药。结论:某院生殖医学中心门诊超说明书用药的现象广泛存在,虽然多数有循证医学证据支持,但也存在不合理用药现象。医院应重视超说明书用药情况,并建立相关管理制度予以规范,临床医师应当谨慎用药,药师应当严谨审方发药,从而降低超说明书用药带来的执业风险,促进医院合理用药水平。

Objective: To analyze the situation of off-labeled drug use in outpatient clinic of reproductive medicine center to provide reference for rational drug use and further standardize off-labeled drug use behavior of physicians. Methods: A retrospective investigation was performed. The prescriptions of Reproductive Medicine Center from January to December 2018 were reviewed,and according to the contents of drug instructions,the off-labeled drug use was statistically analyzed,and the rationality of drug use was analyzed and evaluated by consulting relevant guidelines and literatures. Results: The types of off-labeled medication included over-indication,over-dose and over-administration route. Progesterone injection,L-carnitine oral solution and estradiol/estradiol-didrogesterone tablets were recommended by relevant guidelines at home and abroad with a high level of evidence,and their off-labeled uses were more reasonable. The efficacy of hydroxyethyl starch 200/0. 5 sodium chloride injection,estradiol valerate tablets and coenzyme Q10 tablets was controversial;selenium yeast tablets and vitamin E capsules have not been reported in the relevant literatures,guidelines,authoritative medical monographs at home and abroad,which belonged to empirical medication. Conclusion: It is a widespread phenomenon of off-labeled drug use in outpatient clinic of reproductive medicine center in the hospital. Although most of them are supported by the evidence-based medical evidence,irrational drug uses still exist. Hospitals should attach importance to the situation of drug use beyond the instructions,and establish the relevant management systems to regulate the off-labeled drug use. Clinicians should be cautious to drug use. Pharmacists should strictly examine prescriptions and dispense drugs,so as to reduce the professional risks of drug use beyond the instructions and promote the level of rational drug use in hospitals.