Objective  To establish the drug use evaluation (DUE) standards of roxadustat, and to evaluate its clinical application to promote its rational use.

Methods   Based on the drug labels, referring to relevant guidelines and expert consensus, the DUE criteria for roxadustat were established through the Delphi method, including items such as drug indications, drug use process and the results of medication. A retrospective study was conducted to evaluate the rationality of cases which included inpatients who used roxadustat for the first time from January 1, 2020 to December 31, 2022, with a medication period of more than one month in Fujian Provincial Hospital.

Results  A total of 175 medical records were included, of which 14 records were fully met the clinical application evaluation criteria, and the medication reasonable rate was 8.0%. The unreasonable situation were mainly manifested in the inappropriate clinical outcomes (92.0%), the inappropriate use dosages (52.6%), inappropriate monitoring of adverse reactions (34.9%), inappropriate timing of administration (13.1%), drug interactions (8.7%), inappropriate drug conversion (5.7%), inappropriate efficacy monitoring (4.0%).

Conclusion  The established DUE standards for roxadustat are scientific, practical and feasible, and the evaluation results show a rate of irrationality in the use of roxadustat in the hospital, and it is necessary to standardize the use of roxadustat in terms of dosage, adverse reaction monitoring, and timing of administration.

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