General characteristics, economic burden, causative drugs and medical errors associated with medical damage litigation involving severe cutaneous adverse drug reactions in China

Abstract

What is known and objective To investigate the general characteristics, economic burden, causative drugs and medical errors associated with litigation involving severe cutaneous adverse drug reactions (SCADRs) in China, with the aims of improving rational medication use and reducing the extent of damage from SCADRs. Methods This study analysed 150 lawsuit judgements involving SCADRs from 2005 to 2019, collected from China Judgments Online. Results and discussion In total, 50% of lawsuits stemmed from SCADRs occurring in general hospitals. The average time elapsed from the date of occurrence of the SCADRs to the end of litigation procedures was 1055 days. Of the patients involved, 51% were female and more than two thirds (69%) were under 60 years old. The most common outcome of SCADRs was death (39%), followed by disabilities (30%). The average responsibility of the medical provider was 48 ± 29%. The average amount of compensation was $43 424. Of the cases studied, 51% of SCADRs were Stevens‐Johnson syndrome or toxic epidermal necrolysis, which together accounted for 75% of cases with known clinical subtype. The overall average economic burden of SCADRs was $99 178, of which indirect costs made up the largest proportion (more than 60%). The most common causative drug groups were antimicrobial drugs (49%), Chinese patent medicine and Chinese herbal medicine (17%), and antipyretic analgesics (16%). Finally, 61% of medical errors were found to stem from violation of duty of care, 20% from violation of informed consent and 18% from violations related to the medical record writing and management system. What is new and conclusion Severe cutaneous adverse drug reactions not only severely affect patient survival and quality of life, but also impose a heavy economic burden in terms of health care and societal costs. Medical providers should be better educated on strategies to reduce risk to patients and establish mechanisms of risk sharing and management.

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

“…The medical institution was responsible for 90% of the liability for compensation and reserves the right of patients to follow-up litigation. This result is similar to findings in our previous studies on severe cutaneous ADRs [ 21 ]. Disability often leads to higher compensation levels, which may be related to the increased indirect costs caused by patient disability.…”

“…We found that 41.03% of the cases proceeded to the second or retrial and execution process, which is significantly lower than our previous research on severe cutaneous ADRs (55%) [21], which may be more acceptable to patients given the results of verdicts awarding payments for damages caused by NADs compared to the damage caused by severe cutaneous ADRs. However, medical service providers should still pay attention to the rational use of NADs.…”

“…They are the most original and objective written records that demonstrate the entire process of medical behavior from occurrence to completion. Medical records also constitute legal documents that can serve as evidence for medical appraisal and determination of facts by the courts [ 21 ].…”

“…Litigation cases are published on this platform after judgement. This platform has been used previously to analyze MMLD litigations throughout China [ 21 ]. All information used in this study was obtained from publicly available court records and no confidential or protected health records were obtained.…”

Rates of perceived medical errors and its correlation with work-related factors and personal distress among emergency physicians in China: a national cross-sectional study

“…Moreover, no study explores the relationship between self-perceived medical errors and emergency medicine physicians’ distress. Most of the existing studies in China are from the patients’ perspective, and focus on medical incidents/disputes which had a more serious impact on patient safety 11 12. Some studies investigated patients’ perceptions and attitudes towards doctors after medical errors 13.…”