Guidelines for the management of therapeutic drug monitoring
- VernacularTitle:治疗药物监测管理指南
- Author:
Zhengxiang LI
1
;
Liyan MIAO
2
;
Rong DUAN
1
;
Xiaocong ZUO
3
;
Xianglin ZHANG
4
;
Zhuo WANG
5
;
Miao YAN
6
;
Lingli ZHANG
7
;
Rongsheng ZHAO
8
;
Suodi ZHAI
8
;
Guobiao GAO
9
;
Jinhui TIAN
10
Author Information
1. Dept. of Pharmacy Center，Tianjin Medical University General Hospital，Tianjin 300052，China;Tianjin Center for Drug Utilization Monitoring and Clinical Comprehensive Evaluation，Tianjin 300052，China
2. the First Affiliated Hospital of Soochow University，Suzhou 215006，China
3. the Third Xiangya Hospital，Central South University，Changsha 410013，China
4. Dept. of Pharmacy，China-Japan Friendship Hospital，Beijing 100029，China
5. Dept. of Pharmacy，the First Affiliated Hospital of Naval Medical University，Shanghai 200438，China
6. Dept. of Pharmacy，the Second Xiangya Hospital，Central South University，Changsha 410011，China
7. West China Second University Hospital，Sichuan University，Chengdu 620020，China
8. Dept. of Pharmacy，Peking University Third Hospital，Beijing 100083，China
9. Chinese Pharmacists Association，Beijing 100044，China
10. Institute of Evidence-Based Medicine，School of Basic Medical Sciences，Lanzhou University，Lanzhou 730099，China
- Publication Type:Journal Article
- Keywords:
therapeutic drug monitoring;
management guidelines;
group standard;
evidence-based medicine;
individualized medication
- From:
China Pharmacy
2026;37(11):1381-1392
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To further standardize the technical operations and management processes throughout therapeutic drug monitoring （TDM）， clarify the clinical value of TDM implementation， improve the scientific validity and reliability of monitoring results， and provide a solid reference basis for the formulation and optimization of clinical individualized precision dosing regimens. METHODS The Guidelines for the Management of Therapeutic Drug Monitoring were formulated in accordance with the latest definition of guidelines by the Institute of Medicine of the National Academies and the standard guideline development methodology of the World Health Organization， and in compliance with the requirements of the appraisal of guidelines for research and evaluation. A modified Delphi method was adopted to establish the research question system； evidence-based medicine research methods were applied to systematically search multiple databases to screen the latest and most comprehensive evidence. Evidence was graded and evaluated based on the evidence grading system of the Chinese Evidence-Based Medicine Center， and the grading criteria for recommendation strength from the Oxford Centre for Evidence-Based Medicine were used to determine the recommendation strength. The recommendation opinions were formed through multidisciplinary expert consensus. RESULTS The Guidelines for the Management of Therapeutic Drug Monitoring cover four core modules， including TDM application indications， technical procedures， result interpretation and clinical application， and quality control， involving 18 primary research questions， 34 secondary research questions， and yield 82 recommendations. CONCLUSIONS The guidelines systematically standardize the key technical links and management requirements of the whole TDM process， provide scientific and operable standardized tools， help improve the standardization level of TDM work， promote the translation of monitoring results into clinical decision-making， and provide strong support for precision personalized medicine and ensuring the safety and rationality of medication use.
