{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,21]],"date-time":"2026-02-21T02:27:39Z","timestamp":1771640859447,"version":"3.50.1"},"reference-count":87,"publisher":"Public Library of Science (PLoS)","issue":"6","license":[{"start":{"date-parts":[[2023,6,5]],"date-time":"2023-06-05T00:00:00Z","timestamp":1685923200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100010248","name":"Zhejiang Province Public Welfare Technology Application Research Project","doi-asserted-by":"publisher","award":["2020C35071"],"award-info":[{"award-number":["2020C35071"]}],"id":[{"id":"10.13039\/501100010248","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100017594","name":"Medical Science and Technology Project of Zhejiang Province","doi-asserted-by":"publisher","award":["2020KY086"],"award-info":[{"award-number":["2020KY086"]}],"id":[{"id":"10.13039\/501100017594","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100012248","name":"Collaborative Innovation Center for Modern Science and Technology and Industrial Development of Jiangxi Traditional Medicine","doi-asserted-by":"publisher","award":["2022ZB074"],"award-info":[{"award-number":["2022ZB074"]}],"id":[{"id":"10.13039\/501100012248","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:sec id=\"sec001\">\n<jats:title>Objective<\/jats:title>\n<jats:p>To investigate the general characteristics of litigation cases of medical malpractice liability disputes (MMLDs) related to novel antineoplastic drugs (NADs), the drugs involved, as well as the common types of medical errors related to NADs and their damages in the process of diagnosis and treatment, with the aims of improving the level of rational medication use in the clinical application of NADs and actively prevent medical disputes.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>Methods<\/jats:title>\n<jats:p>The China Judgments Online was searched for the cause of action using the key word \u201cMMLDs\u201d along with the name of 77 kinds of NADs. A total of 39 NAD litigation cases meeting the inclusion criteria from 1 January 2009 to 31 December 2021 were analyzed, and each potential adverse drug reaction (ADR) was reviewed to determine a causality assessment using the Naranjo algorithm for non-drug-induced liver injury (DILI) cases and the updated Roussel Uclaf Causality Assessment Method (RUCAM) for the DILI cases. Risk prevention and control strategies were recommended.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>Results<\/jats:title>\n<jats:p>Cases that met the inclusion criteria increased substantially each year during the last six years, from three cases in 2009\u20132015 to 36 cases in 2016\u20132021. There were more cases in Eastern China than in other geographic regions. Most cases involved tertiary hospitals, patients between 25 and 60 years of age, and patients who were predominately male. There were 18 kinds of NADs involved in medical errors. The most common consequences of NADs were closely related to the death, disability, and increased treatment costs caused by ADRs, inadequate indications, delayed diagnosis and treatment, and misdiagnosis and mistreatment. The most frequent medical errors <jats:bold>were<\/jats:bold> medical technology errors, medical ethics errors and medical record writing\/safekeeping errors. In two cases involving DILI, one case was unable to undergo further RUCAM scoring because the liver function indicators of the patient before and after treatment were not published.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec004\">\n<jats:title>Conclusion<\/jats:title>\n<jats:p>The establishment of mechanisms to reduce the risks associated with the clinical application of NADs is warranted. Healthcare services must maintain strict adherence to the specific requirements of <jats:italic>GPCANADs<\/jats:italic> and drug instructions and strictly grasp the indications, contraindications, usage, and dosage of drugs, and strengthen the notification and management of off-label drug use. Monitoring patients for ADRs and preparing rescue and treatment measures for high-risk drugs may serve to reduce damages related to NADs. For DILI cases, medical and appraisal institutions should use RUCAM score to assess causal relationships.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0286623","type":"journal-article","created":{"date-parts":[[2023,6,5]],"date-time":"2023-06-05T17:23:47Z","timestamp":1685985827000},"page":"e0286623","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":7,"title":["Analysis of medical malpractice liability disputes related to novel antineoplastic drugs and research on risk prevention and control strategies"],"prefix":"10.1371","volume":"18","author":[{"given":"Jinyu","family":"Luo","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6008-745X","authenticated-orcid":true,"given":"Zaoqian","family":"Zheng","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rongliang","family":"Yu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2023,6,5]]},"reference":[{"issue":"3","key":"pone.0286623.ref001","first-page":"1","article-title":"Interpretation and reflection on the guiding principles for the clinical Use of new antitumor medicines","volume":"20","author":"JW Liu","year":"2022","journal-title":"Clin Med J"},{"issue":"16","key":"pone.0286623.ref002","doi-asserted-by":"crossref","first-page":"3029","DOI":"10.1002\/cncr.33587","article-title":"The ever-increasing importance of cancer as a leading cause of premature death worldwide","volume":"127","author":"F Bray","year":"2021","journal-title":"Cancer"},{"key":"pone.0286623.ref003","doi-asserted-by":"crossref","first-page":"616453","DOI":"10.3389\/fphar.2021.616453","article-title":"Off-label use of antineoplastic drugs to treat malignancies: evidence from China based on a nationwide medical insurance data analysis","volume":"12","author":"G Wei","year":"2021","journal-title":"Front Pharmacol"},{"issue":"7","key":"pone.0286623.ref004","doi-asserted-by":"crossref","first-page":"e342","DOI":"10.1016\/S1470-2045(20)30073-5","article-title":"Cancer registration in China and its role in cancer prevention and control","volume":"21","author":"W Wei","year":"2020","journal-title":"The Lancet Oncology"},{"issue":"5","key":"pone.0286623.ref005","doi-asserted-by":"crossref","first-page":"584","DOI":"10.1097\/CM9.0000000000002108","article-title":"Cancer statistics in China and United States, 2022: profiles, trends, and determinants","volume":"135","author":"C Xia","year":"2022","journal-title":"Chin Med J (Engl)"},{"key":"pone.0286623.ref006","first-page":"8","article-title":"Advances in study on novel anti-tumor drugs-induced cardiotoxicity and molecular mechanisms","volume":"01","author":"H Hou","year":"2022","journal-title":"Chin pharm J"},{"key":"pone.0286623.ref007","unstructured":"General Office of National Health Commission[Internet]. 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