Analysis of Labeling Situation of Drug Instructions for Drug Dose Adjustment in Hemodialysis Patients with End-Stage Renal Disease
10.3870/j.issn.1004-0781.2025.03.029
- VernacularTitle:药品说明书中终末期肾病血液透析患者剂量调整信息标注情况分析
- Author:
Siyan LI
1
;
Jianghua SHEN
;
Yan ZENG
;
Yujie QIU
;
Chen SHAO
;
Suying YAN
Author Information
1. 首都医科大学宣武医院药学部,北京 100053;首都医科大学药学院临床药学系,北京 100069
- Publication Type:Journal Article
- Keywords:
Drug instructions;
End-stage renal disease;
Hemodialysis;
Micromedex;
Lexicomp
- From:
Herald of Medicine
2025;44(3):491-496
- CountryChina
- Language:Chinese
-
Abstract:
Objective To investigate the labeling of dialysis-related information in the instructions of drugs for systemic use in patients with end-stage renal disease undergoing hemodialysis,and to provide reference for further standardization and im-provement of drug instructions.Methods Collected the information on pharmacokinetics and drug dose adjustment in hemodi-alysis patients with end-stage renal disease from the instructions of chemicals and biologics used systemically in XuanWu hospital's formulary from January to March 2023.Classified and compared the labeling rates of the corresponding information of the originally developed drugs and generic drugs,imported drugs and domestic drugs;Drugs eliminated by non-renal route,or with mo-lecular weight≥5 000,or binding rate of plasma protein ≥ 60%,or drug distribution volume>360L were classified as"non-dialysis group",and other drugs were classified as"dialysis group",compared the labeling rate of corresponding information of drugs in"dialysis group"and"non-dialysis group";and compared the labeling rate and content with relevant information in Lexicomp and Micromedex.Results Among the 930 drug instructions,the labeling rates of drug dialysis clearance,drug adjustment,and ex-plicit drug adjustment plan were 16.67%,25.16%,and 24.52%.There was no significant difference in the labeling rate of dialysis-related information between original and generic drugs,and imported and domestic drugs.There was a significant difference in the labeling rate of dialysis-related information between the"dialyzable group"and the"non-dialyzable group"(P<0.01).The differ-ence in the labeling rate of dialysis related information between the investigated drug instructions and the corresponding drugs in Lexicomp or Micromedex was statistically significant(P<0.01).Conclusion Attention should be paid to the lack of informa-tion and unclear labeling of hemodialysis patients with end-stage renal disease in the drug instructions by relevant departments.