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Status and Quality of Guidelines for Therapeutic Drug Monitoring Based on AGREE II Instrument

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Abstract

Background

With the progress of therapeutic drug monitoring (TDM) technology and the development of evidence-based medicine, many guidelines were developed and implemented in recent decades.

Objective

The aim was to evaluate the current status of TDM guidelines and provide suggestions for their development and updates based on Appraisal of Guidelines for Research and Evaluation (AGREE) II.

Methods

The TDM guidelines were systematically searched for among databases including PubMed, Embase, China National Knowledge Infrastructure, Wanfang Data, and the Chinese biomedical literature service system and the official websites of TDM-related associations. The search period was from inception to 6 April 2023. Four researchers independently screened the literature and extracted data. Any disagreement was discussed and reconciled by another researcher. The quality of guidelines was assessed using the AGREE II instrument.

Results

A total of 92 guidelines were included, including 57 technical guidelines, three management guidelines, and 32 comprehensive guidelines. The number of TDM guidelines has gradually increased since 1979. The United States published the most guidelines (20 guidelines), followed by China (15 guidelines) and the United Kingdom (ten guidelines), and 23 guidelines were developed by international organizations. Most guidelines are aimed at adult patients only, while 28 guidelines include special populations. With respect to formulation methods, there are 23 evidence-based guidelines. As for quality evaluation results based on AGREE II, comprehensive guidelines scored higher (58.16%) than technical guidelines (51.36%) and administrative guidelines (50.00%).

Conclusion

The number of TDM guidelines, especially technical and comprehensive ones, has significantly increased in recent years. Most guidelines are confronted with the problems of unclear methodology and low quality of evidence according to AGREE II. More evidence-based research on TDM and high-quality guideline development is recommended to promote individualized therapy.

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Acknowledgement

We extend special thanks to Ms. Yu-Meng Lv from Peking University Health Science Center for help with editing. This paper was invited to be presented as a poster at the 12th National Annual Conference on Therapeutic Drug Monitoring.

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Author notes

  1. Zhan-Miao Yi, Xinya Li have contributed equally to this work and share the first authorship.

Authors and Affiliations

  1. Department of Pharmacy, Peking University Third Hospital, 49 North Garden Road, Haidian District, Beijing, 100191, China

    Zhan-Miao Yi, Xinya Li, Zhitong Wang, Jiguang Qin, Dan Jiang, Panhui Tian, Ping Yang & Rongsheng Zhao

  2. Institute for Drug Evaluation, Peking University Health Science Center, Beijing, China

    Zhan-Miao Yi, Xinya Li, Zhitong Wang, Jiguang Qin, Dan Jiang, Panhui Tian, Ping Yang & Rongsheng Zhao

  3. Therapeutic Drug Monitoring and Clinical Toxicology Center, Peking University, Beijing, China

    Zhan-Miao Yi, Xinya Li, Zhitong Wang, Jiguang Qin, Dan Jiang, Panhui Tian, Ping Yang & Rongsheng Zhao

  4. Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University, Beijing, China

    Xinya Li, Jiguang Qin, Dan Jiang & Panhui Tian

Authors
  1. Zhan-Miao Yi
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  8. Rongsheng Zhao
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Contributions

RS Zhao, ZM Yi, and XY Li designed the study. ZM Yi and XY Li searched the literature. ZM Yi, XY Li, ZT Wang, JG Qin, D Jiang, and PH Tian screened the literature. XY Li, JG Qin, ZM Yi, and P Yang conducted data extraction and quality evaluation. ZM Yi and XY Li drafted the manuscript. RS Zhao revised for the finalization of the manuscript. All authors approved the final manuscript.

Corresponding author

Correspondence to Rongsheng Zhao.

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Funding statement

This study was funded by the National Natural Science Foundation of China (72104003).

Conflict of Interest

Zhan-Miao Yi, Xinya Li, Zhitong Wang, Jiguang Qin, Dan Jiang, Panhui Tian, Ping Yang, and Rongsheng Zhao declare that they have no potential conflicts of interest that might be relevant to the contents of this article.

Patient Consent Statement

Written informed consent for participation was not required for this study in accordance with the national legislation and the institutional requirements.

Data Availability Statement

All data generated or analyzed during this study were included in this published article.

Ethics Approval

Not applicable.

Code Availability

Not applicable.

Consent for Publication

Not applicable.

Supplementary Information

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Supplementary file1 (DOCX 106 KB)

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Yi, ZM., Li, X., Wang, Z. et al. Status and Quality of Guidelines for Therapeutic Drug Monitoring Based on AGREE II Instrument. Clin Pharmacokinet 62, 1201–1217 (2023). https://doi.org/10.1007/s40262-023-01283-x

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