Analysis of medical malpractice liability disputes related to novel antineoplastic drugs and research on risk prevention and control strategies

Abstract

Objective 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. Methods The China Judgments Online was searched for the cause of action using the key word “MMLDs” 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. Results Cases that met the inclusion criteria increased substantially each year during the last six years, from three cases in 2009–2015 to 36 cases in 2016–2021. 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 were 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. Conclusion 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 GPCANADs 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.

Advancing perspectives on the off-label use of anticancer drugs: an updated classification and exploration of categories

“…However, the suitability of anticancer medications for off-label use remains controversial due to uncertainty around the clinical benefits and potential toxicities ( Mullins et al, 2010 ; Irwin et al, 2012 ; Eguale et al, 2016 ), limited evidence to support clinical decision-making ( Luo et al, 2023 ; Si and Ma, 2023 ), increased out-of-pocket costs for patients ( Levêque, 2008 ; Mehr, 2012 ), and ethical concerns regarding the lack of informed consent ( Zheng et al, 2017 ). So, in the oncology setting, off-label uses raise increased awareness.…”

Idiosyncratic DILI and RUCAM under One Hat: The Global View

“…In 50/70 cases, there was a possible or unlikely RUCAM-based causality, and among these, the most identified alternative cause of the liver injury was progressive hepatic tumor metastases (56%), while other etiologies included malignant biliary obstruction (4%), non-hepatic disease (9%), and other biliary obstruction or unknown cause (2%) [54]. Due to additional limitations of the study like the retrospective study protocol, data extraction from a so-called self-serve electronic medical record (EMR) search tool, the presented results remain vague with a critical note [54] that prior publications on this topic often have simply described as narratives on the incidence of liver injury during treatment but not adjudicated for the cause [155,156], which was professionally analyzed in medical malpractice liability disputes on iDILI calling for the use of the updated RUCAM [155]. In another narrative report from China published in 2023, the suitability of the updated RUCAM for the iDILI diagnosis related to ICI treatment was unreasonably discussed ignoring actual publications [146].…”