蚌埠市第三人民医院妇产科门诊超说明书用药循证评价标准的应用分析

Application analysis of evidence-based evaluation criteria for off-label drug use in obstetrics and gynecology outpatient department of The Third the People’s Hospital of Bengbu

目的分析蚌埠市第三人民医院妇产科门诊超说明书用药情况,为促进合理用药提供参考。方法通过合理用药软件随机等间距抽取2022年4月1日至2024年3月31日蚌埠市第三人民医院妇产科门诊处方7200张,筛选出超说明书用药的处方,并基于循证医学证据对超说明用药处方进行合理性评价和分析。结果随机抽取的7200张妇产科门诊处方,超说明书用药的处方364张,超说明书用药处方占比为5.06%,共涉及甲硝唑片、米索前列醇片等在内的12种药品,其中超给药途径处方为241张,占比66.21%,超适应证处方105张,占比28.84%,超剂量处方18张,占比4.95%。226张处方超说明书用药无高级别循证医学证据支持,判定为不合理处方,占比62.09%。结论蚌埠市第三人民医院妇产科门诊处方存在超说明书用药的现象,临床确需超说明书用药时应充分权衡利弊,建立相应的超说明书用药管理制度与流程,尽量规避医疗风险,保证临床用药安全。

Objective To analyze the situation of off-label drug use in obstetrics and gynecology outpatient of The Third the People’s Hospital of Bengbu,to provide reference for promoting rational drug use.Methods Through the rational drug use software,7200 prescriptions of the obstetrics and gynecology outpatient department of The Third People’s Hospital Bengbu from April 1,2022 to March 31,2024 were randomly selected at equal intervals,and the prescriptions of off-label drug use were screened out,and the rationality of the prescriptions of off-label drug use was evaluated and analyzed based on evidence-based medical evidence.Results Among the 7200 prescriptions randomly selected in obstetrics and gynecology outpatient clinics,364 were off-label drug use,accounting for 5.06%,involving a total of 12 kinds of drugs,including Metronidazole Tablets,Misoprostol Tablets,among which Among them,there were 241 prescriptions of over-dose route,accounting for 66.21%,105 prescriptions of over-indication,accounting for 28.84%,and 18 prescriptions of over-dose,accounting for 4.95%.226(62.09%)prescriptions of off-label drug use were not supported by high-level evidence-based medical evidence,and were judged as unreasonable prescriptions.Conclusion The phenomenon of off-label drug use exists in the obstetrics and gynecology outpatient prescriptions of The Third People’s Hospital Bengbu.When off-label drug use is really needed in clinic,the pros and cons should be fully weighed,and corresponding off-label drug use management system and process should be established to avoid medical risks as far as possible and ensure clinical drug safety.