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药物过量数据分析:FDA 不良事件报告系统(FAERS)中药物错误报告的回顾。

Medication overdose data analysis: a review of medication error reports in the FDA adverse event reporting system (FAERS).

机构信息

Department of Pharmacy/Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, China.

Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, Chengdu, China.

出版信息

BMC Pharmacol Toxicol. 2023 Aug 4;24(1):41. doi: 10.1186/s40360-023-00681-y.

Abstract

BACKGROUND

drug overdose is a common type of medication error, which caused significant patient injuries and economic losses. To determine which drugs are reported most frequently in association with drug overdose, a comprehensive search was conducted in the FDA Adverse Event Reporting System (FAERS) database. The study also sought to determine the top 10 drugs reported with drug overdose.

METHODS

FAERS database was searched for drug overdose records submitted from the first quarter of 2017 to the fourth quarter of 2021. Descriptive analyses were conducted based on the total counts and percentages of reports associated with the drug. Subgroup analyses were performed on drugs of different pharmacological classifications.

RESULTS

A total of 170,424 drug overdose reports were retrieved. The results revealed that antipyretics and analgesics took the highest risk for overdose, with 63,143 (37.05%) cases reported. Among them, opioids were associated with the most drug overdose events. The top 10 drug classes relating to drug overdose in FAERS were opioid analgesic, anilide antipyretic analgesic, 5-HT reuptake inhibitors, bronchodilators, monoclonal antibodies and antibody-drug conjugates, benzodiazepines, antipsychotics, GABA derivatives, antimanic agents, and propionic acid derivatives.

CONCLUSION

to reduce the occurrence of drug overdose events, some methods could be considered including applying a pre-prescription review system, drug safety education, developing warning lists, etc.

摘要

背景

药物过量是一种常见的用药错误类型,会导致患者严重受伤和经济损失。为了确定与药物过量相关的最常报告的药物,我们在 FDA 不良事件报告系统(FAERS)数据库中进行了全面检索。本研究还旨在确定与药物过量相关的报告数量最多的前 10 种药物。

方法

在 FAERS 数据库中搜索了 2017 年第一季度至 2021 年第四季度提交的药物过量记录。根据与药物相关的报告总数和百分比进行描述性分析。对不同药理学分类的药物进行亚组分析。

结果

共检索到 170424 例药物过量报告。结果表明,解热镇痛药和镇痛药的过量风险最高,有 63143 例(37.05%)报告。其中,阿片类药物与最多的药物过量事件有关。FAERS 中与药物过量相关的前 10 种药物类别是阿片类镇痛药、苯胺类解热镇痛药、5-HT 再摄取抑制剂、支气管扩张剂、单克隆抗体和抗体药物偶联物、苯并二氮䓬类、抗精神病药、GABA 衍生物、抗躁狂药和丙酸衍生物。

结论

为了减少药物过量事件的发生,可以考虑采用预处方审查系统、药物安全教育、制定警示清单等方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f03a/10403938/6e02ecc7f7fe/40360_2023_681_Figc_HTML.jpg

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