《抗肿瘤药物临床应用管理办法》实施现状分析

Implementation of Management Measures for Clinical Application of Anti-tumor Drugs

目的 了解《抗肿瘤药物临床应用管理办法》下发近3年后的实施现状,明确抗肿瘤药物临床应用管理难点,探讨科学管理办法。方法 对某省61家医疗机构抗肿瘤药物临床应用管理现状,从肿瘤专科临床药师培养及肿瘤临床药学工作开展、抗肿瘤药物目录制订、临时采购审批、分级管理、处方/医嘱点评、超说明书用药管理、信息化建设等7个维度进行问卷调查,并对调查数据进行分析。结果 肿瘤专科临床药师的配备率为73.8%;肿瘤专科临床药师配备率高的医院对抗肿瘤药物的管理更为规范;不同医院抗肿瘤药物配备品种数差异较大,尤其是新型抗肿瘤药物,肿瘤专科医院配备率最高;35家(57.4%)医院对抗肿瘤药物施行了分级管理;对肿瘤药物进行分级时主要考虑的是上市时间,其次是不良反应和费用;对医师进行分级授权时主要考虑的因素为职称,其次为专业和工作年限;在施行分级管理的35家医院中,13家(37.1%)医院可以在信息系统上对医师抗肿瘤药物的分级权限进行限制;在处方前置审核环节中,信息化使用率最高(57.4%);在超说明书用药管理中,信息化使用率最低(9.8%);三级医院临时采购流程中临床药师参与率相对较高,临时采购条件较为具体严格;肿瘤专科医院对抗肿瘤药物的管理基本符合管理办法的要求;其他医院尚未较好地执行管理办法的规定,尤其在落实分级管理、超说明书用药管理、对不合理用药的干预以及肿瘤专科临床药师参与多学科会诊和开展药学门诊方面。结论 肿瘤专科医院对抗肿瘤药物的管理相对规范;二级综合医院、中医院、肿瘤之外的专科医院对抗肿瘤药物的管理亟待加强;应更加重视对肿瘤药师人才培养和对合理用药信息化建设的投入。

Objective To determine the implementation of Management Measures for Clinical Application of Anti-tumor Drugs after nearly 3 years of issuance,to clarify the difficulties in the management and to explore management methods.Methods The clinical application and management of anti-tumor drugs in 61 medical institutions in a province were questionnaired from seven aspects,including the training of tumor pharmacists and development of tumor clinical pharmacy,formulation of catalog for anti-tumor drugs,provisional procurement approval,management grading,prescription/doctor’s order comments,off-label drug use,and information network construction.The data were analyzed.Results The equipment rate of tumor pharmacists was 73.8%.The hospital with more tumor pharmacists had better management of anti-tumor drugs.The number of anti-tumor drugs in different hospitals varied greatlly,especially new anti-tumor drugs.Totally 35 hospitals(57.4%)implemented graded management of anti-tumor drugs;Marketing timet,adverse reactions and costs were used as indexes to grade drugs.The main factors to be considered in the authorization of doctors included academic title,followed by specialty and working years.Among the 35 hospitals with hierarchical management,13 hospitals(37.1%)restricted doctors'classification authority of anti-tumor drugs in the information system.The application of information technology was the highest(57.4%)in prescription pre-examination.As for off-label drug management,information technology was least used(9.8%).The participation of clinical pharmacists in the temporary procurement process of tertiary hospitals was relatively high,with specific and strict procurement conditions.The management of anti-tumor drugs in cancer hospitals met the basic requirements of management measures.Other hospitals did not well implement the management measures,especially hierarchical management,off-label drug use,intervention of irrational drug use,and the participation of pharmacists in the oncology department in multidisciplinary and outpatient consultation.Conclusion The management of anti-tumor drugs in cancer hospitals is relatively standardized.It is urgent to strengthen the management of anti-tumor drugs in secondary general hospitals,traditional Chinese medicine hospitals and other hospitals.More attention should be paid to the training of pharmacists and investment in the information network construction for rational drug use.