韩国阿片类药物相关用药差错司法案例分析。

An Analysis of Judicial Cases Concerning Analgesic-Related Medication Errors in the Republic of Korea.

机构信息

Department of Dermatology, Seoul National University Hospital.

Department of Medical Law and Ethics, Graduate School, Yonsei University.

出版信息

J Patient Saf. 2022 Mar 1;18(2):e439-e446. doi: 10.1097/PTS.0000000000000834.

DOI:10.1097/PTS.0000000000000834

PMID:35188932

Abstract

OBJECTIVES

Analgesic-related medication errors can be a threat to patient safety. This study aimed to identify and describe medication errors that can cause serious adverse drug events (ADEs) related to analgesic use.

METHODS

This retrospective, observational, medicolegal study analyzed closed cases concerning complications induced by medication errors involving 3 commonly used analgesics: opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), and acetaminophen (AAP). Cases closed between 1994 and 2019 that were available in the Korean Supreme Court judgment database system were included. Medication errors were categorized using a classification system (developed by our group) based on the stage of drug administration. Clinical characteristics and judgment statuses were analyzed.

RESULTS

A total of 71 cases were included in the final analysis (opioids, n = 30; NSAIDs, n = 35; AAP, n = 6). Among them, 43 claims (60.6%) resulted in payments to the plaintiffs, with a median payment of $86,607 (interquartile range, $34,554-$193,782). The severity of ADEs was high (National Association of Insurance Commissioners scale ≥6) in 88.7% (n = 63) of claims, with a total of 44 (62%) deaths. The most common types of ADEs associated with opioid, NSAID, and AAP use were respiratory depression, anaphylactic shock, and fulminant hepatitis, respectively. The most common recognized medication errors associated with opioid, NSAIDs, and AAP were inappropriate patient monitoring (n = 10; 33.3%), improper analgesic choice (n = 15; 42.9%), and inappropriate treatment after ADEs (n = 3; 50%), respectively.

CONCLUSIONS

Our findings indicate that efforts should be made to reduce medication errors related to analgesic use to prevent permanent injury and potential malpractice claims.

摘要

目的

与镇痛相关的用药错误可能对患者安全构成威胁。本研究旨在确定和描述可能导致与镇痛使用相关的严重不良药物事件（ADE）的用药错误。

方法

本回顾性、观察性、医疗法律研究分析了涉及 3 种常用镇痛药（阿片类药物、非甾体抗炎药（NSAIDs）和对乙酰氨基酚（AAP））的用药错误引起的并发症的封闭病例。纳入了在韩国最高法院判决数据库系统中可获得的 1994 年至 2019 年期间结案的病例。用药错误使用我们小组开发的基于药物管理阶段的分类系统进行分类。分析了临床特征和判决状况。

结果

最终分析共纳入 71 例（阿片类药物 30 例，NSAIDs 35 例，AAP 6 例）。其中，43 项索赔（60.6%）导致向原告支付款项，中位数支付金额为 86607 美元（四分位距 34554-193782 美元）。ADE 的严重程度较高（国家保险专员协会量表≥6），占索赔的 88.7%（n=63），总共有 44 例（62%）死亡。与阿片类药物、NSAIDs 和 AAP 使用相关的最常见 ADE 类型分别为呼吸抑制、过敏性休克和暴发性肝炎。与阿片类药物、NSAIDs 和 AAP 相关的最常见识别出的用药错误分别为不适当的患者监测（n=10；33.3%）、不适当的镇痛选择（n=15；42.9%）和 ADE 后不适当的治疗（n=3；50%）。