Karami Sara, Ventura Christian Angelo I, Pinnow Ellen, Green Jody, Asonye Ajoa, Ibrahim Ibrahim T, McCulley Lynda, Dal Pan Gerald J, Zhou Esther H
Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), 10903 New Hampshire Avenue, Building 22, Room 4202, Silver Spring, MD, 20993, USA.
Clin Drug Investig. 2025 May 28. doi: 10.1007/s40261-025-01444-9.
The coronavirus disease 2019 (COVID-19) pandemic dramatically impacted healthcare systems.
We assessed monthly unintentional pediatric (< 18 years) exposure case rate trends involving selected nonprescription cold and cough (CC), as well as analgesic and antipyretic (AA) drugs, before and during the COVID-19 pandemic, using the National Poison Data System (extracted August 2023).
We included dextromethorphan, guaifenesin, phenylephrine, and pseudoephedrine CC drugs, and acetaminophen, naproxen, ibuprofen, and acetylsalicylic acid AA drugs; statins served as a control. We performed descriptive analyses involving single-product unintentional pediatric exposure cases overall, by sex, and by age. We performed interrupted time series (ITS) analyses, modeling associations between the pandemic's immediate and sustained effects, adjusting for population and seasonality.
Overall, apart from the control, acetylsalicylic acid, and naproxen drugs, monthly unintentional single-product exposure case rates decreased sharply at the pandemic's onset. In ITS analyses, rates decreased most notably for cases involving children < 6 years old, where unintentional-general and unintentional-therapeutic error case rates statistically significantly fell by 1.8-12.6 cases per million population at the pandemic's onset. During the pandemic, case rates gradually increased to pre-pandemic levels within 1.5 years. For cases involving children < 6 years old, these exposure case rates statistically significantly rose by 0.1-0.6 cases per million population per month compared with pre-pandemic levels. Monthly case rate patterns for cases 6-12 years old mirrored those of cases < 6 years old, with less pronounced level and trend changes.
These findings underscore the need for continuously adapting public health strategies to ensure drug safety during prolonged periods of public health emergencies.
2019冠状病毒病(COVID-19)大流行对医疗系统产生了巨大影响。
我们使用国家毒物数据系统(于2023年8月提取)评估了COVID-19大流行之前和期间,涉及选定非处方感冒和咳嗽(CC)药物以及止痛和解热(AA)药物的18岁以下儿童每月意外暴露病例率趋势。
我们纳入了右美沙芬、愈创甘油醚、去氧肾上腺素和伪麻黄碱CC类药物,以及对乙酰氨基酚、萘普生、布洛芬和乙酰水杨酸AA类药物;他汀类药物作为对照。我们对总体、按性别和按年龄的单产品儿童意外暴露病例进行了描述性分析。我们进行了中断时间序列(ITS)分析,对大流行的即时和持续影响之间的关联进行建模,并对人口和季节性进行了调整。
总体而言,除对照药物、乙酰水杨酸和萘普生药物外,在大流行开始时,每月单产品意外暴露病例率急剧下降。在ITS分析中,涉及6岁以下儿童的病例率下降最为显著,在大流行开始时,意外一般和意外治疗错误病例率每百万人口统计学显著下降1.8 - 12.6例。在大流行期间,病例率在1.5年内逐渐上升至大流行前水平。对于涉及6岁以下儿童的病例,与大流行前水平相比,这些暴露病例率每月每百万人口统计学显著上升0.1 - 0.6例。6至12岁病例的每月病例率模式与6岁以下病例相似,但水平和趋势变化不太明显。
这些发现强调了在长期公共卫生紧急情况下,需要不断调整公共卫生策略以确保药物安全。