ArticleBMC health services research2023
Judicial and legislative practice and related suggestions on off-label drug use in China.
Article in BMC health services research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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Who cites it
4 citing papers in PubMed.
- Exploring pediatricians' off-label prescribing behavior in China: A theory of planned behavior-based study.International journal of clinical pharmacy · 2025Article
- A Critical Appraisal of Off-Label Use and Repurposing of Statins for Non-Cardiovascular Indications: A Systematic Mini-Update and Regulatory Analysis.Journal of clinical medicine · 2025Article
- Off-label drug use in China after the Physician Law (2021): legal challenges and solutions.Frontiers in pharmacology · 2025Article
- Advancing perspectives on the off-label use of anticancer drugs: an updated classification and exploration of categories.Frontiers in pharmacology · 2024Review
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Authors and funding
2 authors.
Funding
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Abstract
backgroundOff-label drug use exists widely in medical practice and is also an area which easily triggers controversy between patients and medical institutions. Previous studies have identified the reasons why off-label drug use long exists. However, there is no multidimensional analysis on real judicial precedents about off-label drug use. This study aimed to investigate the dispute points on off-label drug use based on real cases in China, and proposed suggestions based on newly-leased Physicians Law.
methodsOur study is a retrospective study with all the 35 judicial precedents on off-label drug use extracted from China Judgments Online from 2014 to 2019. This study mainly used the methods of statistical analysis, inferential analysis, exemplification, literature summarization and comparative analysis.
resultsAccording to the analysis of the 35 precedents of jurisdictions from 11 different aspects, it can be seen that the second-instance and retrial rates of this kind of cases are high, and the disputes between patients and medical institutions are fierce. In judicial practice of off-label drug use, medical institutions are determined whether to bear civil liability according to the constituent elements of medical tort liability: the rate of medical institutions' bearing liability for off-label drug use is not high, and medical institutions are not directly identified as infringing acts and they don't bear tort liability. The clear provisions about off-label drug use in Law of the People's Republic of China on Physicians which was implemented in March 2022 confirm this at the legislative level.
conclusionsBy analyzing the current judicial practice of China's off-label drug use cases, and summarizing the dispute points between medical institution and patients, the constituent elements of tort liability, and the rules of evidence etc., suggestions are proposed to further regulate off-label drug use and promote safe and rational drug use.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.