武汉城市圈治疗药物浓度监测开展情况调查

Survey on the monitoring of therapeutic drug concentration in Wuhan metropolitan area

目的:了解武汉城市圈医疗机构治疗药物监测(therapeutic drug monitoring,TDM)工作开展情况。方法:设计网络调查问卷,调查内容包括医疗机构开展TDM工作的基本情况、人员、仪器、方法、监测种类与样本量、制度、科学研究和观点看法等,调查对象为武汉药学会治疗药物监测专委会的48家委员单位,采用SPSS软件对数据进行描述性统计。结果:共纳入46份有效问卷,其中41家医院开展TDM工作:30家自行开展,11家委托第三方。自行开展单位TDM岗位人数中位数为3人,人员专业以药学、学历以硕士、职称以中级为主,约1/3单位的TDM从业人员无相关资质证明。TDM方法以免疫法居多,HPLC及LC-MS法日渐普及,但剂量调整软件和群体药动学模型涉及较少。41家单位可开展TDM的项目种类共计74种,中位数为6项;精神类药物、免疫抑制剂、抗生素、甲氨蝶呤和地高辛等TDM证据充分药物的开展单位较多,年样本量较大;不同单位在开展TDM项目种类和2021年检测样本量方面差异较大;部分专科医院开展TDM具有病种优势。超半数单位建立了TDM工作制度(70.7%)和项目审批制度(61.0%);66.7%单位的项目室内质控覆盖率达100%,但仍有2家单位未开展室内质控;56.7%单位未参加室间质评。除提供检测数值外,超半数单位还提供解读报告(70.7%)、参与剂量调整(53.6%)和开展TDM科普宣传(53.6%),仅有26.8%的单位鼓励实验室自建方法用于TDM。不同医疗机构在开展TDM相关临床试验、获得基金课题和发表论文等方面差异较大,大多数单位的TDM相关科研处于起步阶段。与医生开展TDM研究、得到行政部门的财政、政策支持及分析结果和解读报告的及时性被认为是有助于建立成功TDM项目的三大因素;费用报销、医生对TDM的接受度低及TDM操作障碍被认为是影响TDM项目成功的三大障碍。结论:该调查获得了武汉城市圈医疗机构开展TDM工作的多维度现状,在TDM人员资质与岗位培训、个体化方案制定、质量控制、科学研究及管理等方面存在发展不充分的情况,为后续TDM工作的提升提供了努力方向。

OBJECTIVE To investigate the implementation of therapeutic drug monitoring(TDM)in medical institutions in Wuhan metropolitan area.METHODS An online survey questionnaire was designed,focusing on various aspects of TDM in medical institutions,including basic situation,personnel,instruments,methods,types and volume of monitoring,policies,scien⁃tific research,and opinion about TDM.The survey targeted 48 member units of the Division of Therapeutic Drug Monitoring of Wuhan Pharmaceutical Association.Analyses were performed using IBM SPSS Statistics 23.RESULTS A total of 46 valid questionnaires were included.Among the 46 hospitals,41 hospitals conducted TDM.30 of them provided TDM service in their own laboratories and 11 provided the service through third-party laboratories.The median number of staffs in in-house TDM labo⁃ratories was 3,primarily comprising pharmacists with master degrees and intermediate professional titles.Approximately one third of TDM practitioners lacked relevant qualifications.Although HPLC and LC-MS methods became increasingly popular in TDM,immune methods were still the most common.However,dose adjustment software and population pharmacokinetic model were rarely utilized.The 41 institutions collectively monitored 74 types of TDM projects,with a median of 6 per institution.There were more institutions engaged in the monitoring of well-evidenced medication such as psychotropic drugs,immunosuppressants,antibiotics,methotrexate,and digoxin,with larger annual sample size.There were significant differences among different institu⁃tions in terms of the types of TDM projects and the number of samples tested in 2021.Some specialized hospitals had advantages in conducting TDM for specific diseases.More than half of the hospitals had established TDM management system(70.7%)and TDM project approval system(61.0%).The coverage rate of internal quality control was 100%in two thirds of hospitals,but two hospitals did not implement internal quality control.56.7%of the hospitals did not participate in inter-laboratory quality assessment.Besides providing test results,more than half of the hospitals also provided interpretation reports(70.7%),partici⁃pated in dose adjustment(53.6%)and carried out TDM public education(53.6%).Only 26.8%of the hospitals encouraged laboratories to develop self-built test method for TDM.In terms of scientific research related to TDM,the performance of differ⁃ent hospitals varied widely in clinical trials,obtaining funding for research projects and publication of articles.Most institutions were in the initial stages of TDM-related research.Collaborations with physicians on TDM research,ensuring financial and man⁃agement support from administrative departments,and producing,interpreting,and reporting results in a clinically acceptable time⁃frame were considered to be the top three key factors to establishing successful TDM programs.Expense reimbursement,low acceptance of TDM by clinicians,and operational constraints,particularly precise timing between dosing and sampling were con⁃sidered as the top three obstacles to the success of TDM programs.CONCLUSION The questionnaire survey objectively reflected a multi-dimensional overview of the current situation of TDM performed by medical institutions in Wuhan metropolitan area.It identified areas where further development is needed,such as personnel qualifications and training,individualized dosage design,quality control,scientific research,clinical interpretation and management.This information can serve as a basis for improving TDM work in the future.