Total score and resulting causality grading.

ObjectiveTo 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.MethodsThe 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.ResultsCases 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.ConclusionThe 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.

研究目的：本研究旨在探讨新型抗肿瘤药物（novel antineoplastic drugs, NADs）相关医疗损害责任纠纷（medical malpractice liability disputes, MMLDs）诉讼案件的一般特征、涉案药物类型，以及新型抗肿瘤药物相关常见医疗差错类型及其在诊疗过程中造成的损害后果，以期提升新型抗肿瘤药物临床应用的合理用药水平，主动防范医疗纠纷。
研究方法：本研究以中国裁判文书网为检索平台，以“医疗损害责任纠纷（MMLDs）”为案由关键词，结合77种新型抗肿瘤药物名称进行检索。最终筛选2009年1月1日至2021年12月31日期间符合纳入标准的39例新型抗肿瘤药物相关诉讼案件进行分析；对每一例可疑药物不良反应（adverse drug reaction, ADR）进行回顾，针对非药物性肝损伤（drug-induced liver injury, DILI）病例采用Naranjo量表进行因果关系评估，药物性肝损伤病例则采用更新版Roussel Uclaf因果关系评估量表（Roussel Uclaf Causality Assessment Method, RUCAM）进行评估，并提出风险防控策略。
研究结果：纳入分析的案件数量在近六年呈显著增长趋势，2009-2015年仅3例，2016-2021年增至36例。华东地区涉案案件数量多于其他地理区域。涉案医疗机构多为三级医院，患者年龄集中在25-60岁，且以男性居多。本次研究共涉及18种存在医疗差错的新型抗肿瘤药物。新型抗肿瘤药物相关不良后果多与药物不良反应、适应证不足、诊疗延误、误诊误治引发的死亡、残疾及治疗成本增加密切相关。最常见的医疗差错类型为医疗技术差错、医德医风差错及病历书写/保管差错。在2例药物性肝损伤病例中，1例因未公布患者治疗前后肝功能指标，无法开展进一步RUCAM评分。
研究结论：建立健全新型抗肿瘤药物临床应用风险防控机制具有必要性。医疗机构需严格遵循GPCANADs及药品说明书要求，精准掌握药物的适应证、禁忌证、用法与用量，加强超说明书用药的告知与管理。对患者开展药物不良反应监测，并为高风险药物制定急救与治疗方案，可有效降低新型抗肿瘤药物相关损害后果。针对药物性肝损伤病例，医疗及鉴定机构应采用RUCAM量表进行因果关系评估。