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Trends in Adverse Drug Reactions Among Children: Evidence from Jiangsu Province of China, 2010–2019

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Abstract

Background

Medication safety among children represents an underrecognized public health concern worldwide, yet little evidence was found in China. This study aimed to examine trends in rates of pediatric adverse drug reaction (ADR) reports in Jiangsu Province of China with a catchment population of more than 11 million children.

Methods

Data for children aged under 15 years were extracted from the spontaneous reporting system of ADR surveillance in Jiangsu Province. Suspected therapeutic agents for ADRs were coded using the Anatomical Therapeutic Chemical classification system. We used the Chinese modification of the International Classification of Diseases, Tenth Revision, to group primary diseases, and the Medical Dictionary for Regulatory Activities to classify the manifestation of ADRs. We used Joinpoint to estimate age-adjusted ADR rates stratified by sex from July 2010 to June 2019, and further by specific features, including patient characteristics, main suspected therapeutic medications, primary diseases, and ADRs. We used the percentage change annualized estimator to evaluate trends over time.

Results

A total of 79,903 ADR reports were identified among children aged under 15 years, which accounted for 11.4% of all ADRs reported in Jiangsu Province during the same period. The age-adjusted ADR report rates increased significantly from 66.20 to 96.76 per 100,000 children during the period July 2010–June 2019, with an annual increase of 4.9% (95% confidence interval 1.3–8.5%; p value 0.014). Of all ADR reports, there were 47,774 (59.8%) boys and 32,129 (40.2%) girls. Children aged 0–4 years accounted for more than half of the ADR reports (n = 47,680, 59.7%). Skin and subcutaneous tissue disorders were the most frequently reported ADRs (45,773, 57.3%). Respiratory diseases were the most commonly observed medical conditions in relation to pediatric ADRs, accounting for 68.8% (n = 54,940) of all ADR reports, and anti-infectives for systemic use consistently represented over time the most common medication group, contributing to 69.8% of all reports. A reduction in ADR report rates was observed for vaccines, with an annual decrease of 19% in children.

Conclusions

ADRs remain a public health challenge among the vulnerable pediatric populations. Findings from the present study call for continuing efforts in ADR prevention and medication safety improvement in children.

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Author information

Author notes

  1. Hui Xue and Ming Li contributed equally to this manuscript.

Authors and Affiliations

  1. School of Public Health, Southeast University, Nanjing, 210009, China

    Hui Xue, Lijun Fan & Wei Du

  2. College of Life Science and Technology, China Pharmaceutical University, Nanjing, 210009, China

    Ming Li

  3. Jiangsu Center for ADR Monitoring, Nanjing, 210002, China

    Ming Li

  4. Department of Clinical Pharmacology, Nanjing First Hospital, Nanjing Medical University, Nanjing, 210006, China

    Jianjun Zou

Authors
  1. Hui Xue
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  4. Wei Du
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Corresponding authors

Correspondence to Wei Du or Jianjun Zou.

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Authors’ contributions

WD and JZ conceptualized and designed the study; HX and ML conducted the data analysis; and HX wrote the first draft of the manuscript. All authors contributed to the critical review, interpreted the study data, and revised the manuscript. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.

Funding/support

This study was supported by the Department of Education (no. 1125000172), Fundamental Research Funds for the Central Universities (no. 3225002002A1), and the National Natural Science Foundation of China (Grant numbers 71704192, 82173899).

Conflict of interest

No financial or non-financial benefits have been received or will be received from any party relating directly or indirectly to the subject of this article. Hui Xue, Ming Li, Lijun Fan, Wei Du, and Jianjun Zou have no conflicts of interest to declare.

Availability of data and material

The datasets generated during the current study are not publicly available. Aggregated data may be available from the corresponding author upon reasonable request.

Ethics approval

This study was approved in accordance with the ethical review and data use agreement with Jiangsu Center for ADR Monitoring (JSADR #2021/0101).

Consent to participate

Informed consent was not required for this study due to its analytic nature of anonymous and aggregated data.

Consent for publication

Not applicable

Code availability

Analytic codes were available upon reasonable request made to the corresponding authors.

Supplementary Information

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Xue, H., Li, M., Fan, L. et al. Trends in Adverse Drug Reactions Among Children: Evidence from Jiangsu Province of China, 2010–2019. Pediatr Drugs 25, 97–114 (2023). https://doi.org/10.1007/s40272-022-00539-6

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