Risk signal mining of adverse events related to azithromycin in children based on US FDA Adverse Event Reporting System database and establishment of related pharmaceutical care process
10.3760/cma.j.cn114015-20240705-00523
- VernacularTitle:基于美国FDA不良事件报告系统数据库的儿童使用阿奇霉素不良事件风险信号挖掘及相关药学监护流程的建立
- Author:
Qinglan LIU
1
;
Jianing ZHANG
1
;
Jingsai SONG
1
;
Zhifeng NIE
1
;
Yanli REN
1
;
Wenhui YANG
1
Author Information
1. 郑州大学第三附属医院药学部，郑州 450052
- Publication Type:Journal Article
- Keywords:
Mycoplasma pneumonia;
Macrolides;
Azithromycin;
Children;
Data mining;
Adverse event reporting system;
Pharmaceutical care;
Medication safety officer
- From:
Adverse Drug Reactions Journal
2024;26(12):737-742
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To mine the adverse events (AE) risk signal of azithromycin in children, establish the corresponding pharmaceutical care process, and provide reference for the safe use of azithromycin in clinic.Methods:AE caused by azithromycin in children (<18 years) were searched from the US FDA Adverse Event Reporting System (FAERS) database from the 1st quarter of 2004 to the 4th quarter of 2023. The AE was standardized and classified using the preferred term (PT) and system organ class (SOC) in the Medical Dictionary for Regulatory Activities 26.1 version. Reporting odds ratio (ROR) and proportional reporting ratio (PRR) methods were used for detection of AE signal of azithromycin. AE that simultaneously met the following conditions was considered as a risk signal: the number of reports≥3, lower limit of the 95% confidence interval of ROR≥1, PRR>2, and χ2>4. Descriptive analysis on the signals was performed. The pharmaceutical care process of azithromycin for children was established based on the results of signal mining and satisfaction survey was conducted. Results:A total of 1 457 AE reports related to azithromycin in children were collected, involving 127 PTs and 18 SOCs. The top 5 PTs in the number of reports were rash, pruritus, urticaria, drug hypersensitivity and diarrhea. The top 5 PTs in signal intensity were infantile diarrhea, myasthenia gravis crisis, intermittent explosive disorder, diarrhea neonatal, and infantile vomiting. A total of 16 risk signals that were not recorded in the label were mined out, and the top 5 PTs according to signal intensity were intermittent explosive disorder, conversion disorder, bronchiectasis, tooth discoloration, and choreoathetosis. The analysis of 79 AE reports with death outcomes showed that drug-induced liver injury, Stevens-Johnson syndrome, rash, vomiting, nausea, cyanosis, and diarrhea were related risk signals. Based on the signal mining results mentioned above, the medication safety officer team in our hospital established a pharmaceutical care process of azithromycin application for children, including pre-medication assessment (indications, medical history, heart and liver function, etc.), speed and mode of administration monitoring during the medication, and intervention measures after the occurrence of adverse reactions, and 178 hospitalized children who received azithromycin treatment were monitored. The satisfaction survey results showed the degree of satisfaction was 100%.Conclusions:The main AEs related to azithromycin in children are rash, pruritus, urticaria, drug hypersensitivity, and diarrhea, all of which are recorded in the label. In addition, we should also be vigilant against the risk signals such as intermittent explosive disorder, conversion disorder, bronchiectasis, tooth discoloration, and choreoathetosis, which are not recorded in the label. The pharmaceutical care process for azithromycin use in children based on the risk signal mining results is feasible and effective.
