Construction and application evaluation of off-label drug use evaluation system in cancer hospital
- VernacularTitle:肿瘤专科医院超说明书用药评价体系的构建与应用评价
- Author:
Jinglin LIU
1
,
2
;
Weiping WANG
2
,
3
;
Hongtao WANG
2
,
3
;
Ning GAO
1
,
2
;
Chao ZHANG
1
,
2
;
Xibei ZHOU
2
,
3
;
Chunnuan WU
1
,
2
;
Lu LU
1
,
2
;
Jie ZHANG
1
,
2
;
Xiaokun SONG
1
Author Information
1. Dept. of Pharmacy，Tianjin Medical University Cancer Institute & Hospital，Tianjin 300060，China
2. National Clinical Research Center for Cancer/Tianjin’s Clinical Research Center for Cancer/Key Laboratory of Breast Cancer Prevention and Therapy，Tianjin Medical University，Ministry of Education/Tianjin Key Laboratory of Cancer Prevention and Therapy，Tianjin 300060，China
3. Dept. of Medical Affairs，Tianjin Medical University Cancer Institute & Hospital，Tianjin 300060，China
- Publication Type:Journal Article
- Keywords:
off-label drug use;
anti-tumor drugs;
evaluation system;
evidence-based reference
- From:
China Pharmacy
2024;35(17):2082-2087
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To provide reference for strengthening the standardized management of off-label drug use in cancer hospitals. METHODS The evaluation system for off-label drug use was established to standardize the application， approval， and filing process for off-label drug use in our hospital. The changes in off-label drug application quantity， proportion， disease category and drug category in our hospital were compared before （October 1st， 2021-September 30th， 2022） and after （October 1st， 2022- September 30th， 2023） the establishment of the evaluation system； drug items supported by high-level evidence screened by pharmacy department were analyzed statistically. RESULTS The number of off-label drug use applications in our hospital had gradually increased， from 306 pieces in the fourth quarter of 2021 to 3 828 pieces in the third quarter of 2023. In the year before the construction of the evaluation system， there were a total of 4 482 applications for off-label drug use， and in the year after the construction of the evaluation system， there were 11 840 applications for off-label drug use. After the construction of the evaluation system， the proportion of unregistered off-label drug use significantly decreased， compared to the same period last year （P＜0.05）. Among them， there were no unregistered applications for off-label drug use for digestive system tumors， head and neck tumors， and radioactive drugs； lymphoma， breast tumors，urogenital system tumors， cytotoxic drugs and new anti-tumor drugs all had a decrease of over 70% in unregistered off-label drug applications. Twenty-seven off-label drug use items related to 19 drugs supported by high-level evidence were screened by the pharmacy department of our hospital， among which 25 items were drug use beyond indication. CONCLUSIONS The establishment of off-label drug use evaluation system in cancer hospital is helpful to the rational use and refined management of clinical anti-tumor drugs.
