2000张门诊抗肿瘤药处方超药品说明书用药情况分析

Analysis of Off-Label Use of 2000 Outpatient Anti-Tumor Drug Prescriptions

目的:了解该院门诊抗肿瘤药超药品说明书用药的情况。方法:随机抽取2021年该院门诊药房抗肿瘤药处方2000张,根据药品说明书,统计门诊抗肿瘤药在剂量、适应人群、适应证和给药途径方面的超药品说明书用药情况,进行评价和分析。结果:该院抗肿瘤药超药品说明书用药发生率为31.50%(630/2000)。男性患者超药品说明书用药处方所占比例明显高于女性患者(χ^(2)=21.33,P=0.00),主任医师超药品说明书用药处方所占比例显著低于主治医师(χ^(2)=38.72,P=0.00)、副主任医师(χ^(2)=31.09,P=0.00),差异均有统计学意义。630张超药品说明书用药处方中,超药品说明书用药类型主要为超给药途径(266张,占42.22%)和超适应证给药(235张,占37.30%);抗肿瘤化疗药(397张,占63.02%)、靶向药物(129张,占20.48%)超药品说明书用药现象较多;消化系统肿瘤(182张,占28.89%)、胸部肿瘤(165张,占26.19%)及泌尿系统肿瘤(107张,占16.98%)超适应证用药现象较多。结论:目前,该院抗肿瘤药普遍存在超药品说明书用药的现象,主要类型为超适应证用药和超给药途径用药,需予以重视,以科学、合理的管理方式保证患者用药有效、安全。

OBJECTIVE:To probe into the off-label use of anti-tumor drugs in the hospital.METHODS:Totally 2000 prescriptions with anti-tumor drugs were randomly selected from the outpatient pharmacy of the hospital in 2021.According to the drug instructions,the off-label use of anti-tumor drugs in the outpatient department in terms of dosage,suitable population,indication and route of administration was analyzed and evaluated.RESULTS:The incidence of off-label use of anti-tumor drugs in the hospital was 31.50%(630/2000).The proportion of off-label drug use prescriptions in male patients was significantly higher than that in female patients(χ^(2)=21.33,P=0.00),and the proportion of off-label drug use prescriptions in chief physicians was significantly lower than that in attending physicians(χ^(2)=38.72,P=0.00)and associate chief physicians(χ^(2)=31.09,P=0.00),with statistical significant differences.Among the 630 off-label drug use prescriptions,the main types of off-label drug use were off-label route of administration(266 prescriptions,42.22%)and off-label indications(235 prescriptions,37.30%).Anti-tumor chemotherapeutic drugs(397 prescriptions,63.02%)and targeted drugs(129 prescriptions,20.48%)took the lead of off-label drug use.There were more off-label indications for the digestive system tumors(182 prescriptions,28.89%),chest tumors(165 prescriptions,26.19%)and urological tumors(107 prescriptions,16.98%).CONCLUSIONS:Off-label drug use of anti-tumor drugs is widespread in the hospital,mainly off-label indications and off-label route of administration,which need to be taken seriously to ensure the effective and safe use of drugs by patients in a scientific and rational management manner.