Analysis of the Development Status of Neuropsychiatric Therapeutic Drug Monitoring in Terms of the External Quality Evaluation / 中国药房

ABSTRACT

OBJECTIVE： To analyze the development status of neuropsychotropic therapeutic drug monitoring （TDM）， and to provide reference for improving the quality of TDM in neuropsychiatry department. METHODS： The laboratory data of neuropsychotropic TDM external quality assessment （EQA） were collected from Website of Clinical Laboratory Center of Ministry of Health （http：//www.clinet.com.cn） during 2008-2017， and then analyzed statistically in respects of TDM project， the number of involved laboratory， monitoring method， etc. RESULTS： By the end of 2017， the Clinical Laboratory Center of the Ministry of Health had conducted 5 neuropsychiatric TDM projects involving 4 drugs， including 3 items of serum TDM （carbamazepine， valproic acid， phenytoin）， lithium ion monitoring （lithium carbonate） in biochemical routine and newly added pharmacokinetic laboratory biological sample monitoring （carbamazepine） in 2014. From 2008 to 2017， the number of involved laboratories increased from 209 to 603， with carbamazepine （serum， plasma） and valproic acid showing good annual growth trend， exceeding 200 and phenytoin 107， but only 27 in lithium carbonate until 2017. Among all monitoring methods of involved laboratories， the number of laboratories which adopted fluorescence polarization immunoassay （FPIA） decreased year by year. By the end of 2017， there were fewer than 10 laboratories. The number of laboratories using acridinium direct chemiluminescence， enzyme-multiplied immunoassay technique （EMIT）， and high performance liquid chromatography （HPLC） had steadily increased. By the end of  2017， acridinium direct chemiluminescence was the most used in laboratory， followed by EMIT and HPLC. CONCLUSIONS： Due to the increasing number of participating laboratories， it can be seen that the consciousness of quality control of laboratory personnel is increasing day by day； but the complexity of TDM monitoring methods limits the types of drugs used in external quality evaluation. It is suggested to formulate guidelines， quality control standards and operation rules as soon as possible， so as to ensure the accuracy of test results.