Correlation analysis between the judgment of medical damage liability disputes related to off-label drug use and evidence-based evidence
- VernacularTitle:超说明书用药医疗损害责任纠纷判决与循证证据的相关性分析
- Author:
Qi BAO
1
;
Lin HU
1
;
Huajie HU
1
;
Tao HUANG
1
;
Mengyuan FU
1
;
Wushouer HAISHAERJIANG
2
;
Xiaodong GUAN
2
;
Luwen SHI
1
Author Information
1. Dept. of Pharmacy Administration and Clinical Pharmacy，School of Pharmaceutical Sciences，Peking University，Beijing 100191，China
2. Dept. of Pharmacy Administration and Clinical Pharmacy，School of Pharmaceutical Sciences，Peking University，Beijing 100191，China;International Research Center for Medicinal Administration，Peking University，Beijing 100191，China
- Publication Type:Journal Article
- Keywords:
off-label drug use;
medical damage liability
- From:
China Pharmacy
2022;33(15):1810-1813
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To explore wheth er there is a relationship between the judgment results of medical damage liability disputes related to off-label drug use and evidence-based evidence. METHODS By searching for medical damage liability disputes related to off-label drug use up to 2021 on pkulaw.cn ，documents were extracted to record objective factors ，subjective factors and judgment results ；whether there was evidence-based evidence was judged according to Off-label Drug Use List and Evidence-based Evaluation Standards for Off-label Drug Use of Guangdong Pharmaceutical Association ；univariate analysis was adopted to test the relationship between the judgment results and evidence-based evidence. RESULTS A total of 57 cases were included. Cases mainly occurred in the eastern China （63.2％）and tertiary hospitals （64.9％），the main appraisal agency was the appraisal center or institute（61.4％），and the most common type of off-label drug use was overdose drug use （45.6％）. Among the judgment results ， 23 cases（40.4％）of off-label drug use had a causal relationship with medical damage ，most of the responsibility of doctors was secondary responsibility （28.1％），and the actual compensation amount of the most cases were less than 100，000 yuan（54.4％）. There were 25 cases（43.9％）with evidence-based evidence. Univariate analysis found that for off-label drug use the claim amount of the case with evidence-based evidence was significantly higher than that of the case without evidence-based evidence （P＝ 0.040），and there was no significant correlation between evidence-based evidence and the actual compensation amount of the case （P＝0.741），causality determination （P＝0.256），liability type （P＝0.598）or appraisal agency （P≥0.260）. CONCLUSIONS There is no significant correlation between the judgment results of medical damage liability disputes related to off-label drug use and evidence-based evidence ，indicating that there may be certain differences between judicial trials and medical science. The off-label drug use should be regulated by establishing a complete off-label drug use management system and standardizing informed consent procedure for off-label drug use. 1610307322@pku.edu.cn
