Journal List > Allergy Asthma Respir Dis > v.6(5) > 1102179

Allergy Asthma Respir Dis. 2018 Sep;6(5):263-269. Korean.
Published online September 28, 2018.  https://doi.org/10.4168/aard.2018.6.5.263
© 2018 The Korean Academy of Pediatric Allergy and Respiratory Disease; The Korean Academy of Asthma, Allergy and Clinical Immunology
Analysis of pediatric adverse drug reactions reported to regional pharmacovigilance center of a single university hospital
Do-Woo Kim,1 Yun-Chang Choi,1 Young-Seok Lee,1 Young-Hee Nam,2 and Jin-A Jung1
1Department of Pediatrics, Dong-A University College of Medicine, Busan, Korea.
2Department of Internal Medicine, Dong-A University College of Medicine, Busan, Korea.

Correspondence to: Jin-A Jung. Department of Pediatrics, Dong-A University College of Medicine, 32 Daesingongwon-ro, Seo-gu, Busan 49201, Korea. Tel: +82-52-240-5617, Fax: +82-51-242-2765, Email: jina1477@dau.ac.kr
Received March 23, 2018; Revised June 28, 2018; Accepted June 30, 2018.

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/).


Abstract

Purpose

Adverse drug reactions (ADRs) are a recurring problem among pediatric patients, and the incidence is increasing. However, there have been only a few studies on the clinical presentation of pediatric ADRs in Korea. This study investigated the clinical presentation of ADRs and the causative drugs in pediatric patients from a single university hospital.

Methods

We retrospectively collected the data on pediatric ADRs as reported to the Regional Pharmacovigilance Center in Dong-A University Hospital between March 2013 and July 2016. We analyzed clinical presentations associated with the events. To determinate causality, we evaluated each ADR according to the Naranjo probability scale, the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) criteria and the Korean ADR algorithm.

Results

A total of 365 ADR cases were reported. Sixty-eight patients (26.5%) responded to 2 or more drugs. Antibiotics (43.3%) were the most common causative drugs, of whom the third generation cephalosphorins caused most ADRs. The most common clinical presentations were gastrointestinal manifestations (36.6%). A total of 312 ADRs were reported in 257 patients based on both the Naranjo probability scale and the Korean ADR algorithm. In addition, 323 ADRs were reported in 257 patients based on the WHO-UMC criteria.

Conclusion

Various drugs are related to ADRs in pediatric patients. Further efforts to improve ADR-reporting systems and to increase awareness of ADRs in pediatric patients are needed.

Keywords: Adverse drug reactions; Child; Antibiotics

Figures


Fig. 1
Causality assessment of adverse drug reactions by Naranjo's scale, WHO-UMC, and Korean algorithm, respectively. WHO-UMC, World Health Organization-Uppsla Monitoring Centre.
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Tables


Table 2
Frequency of drug to cause the adverse reactions by age distribution
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Table 3
Frequency of drug to cause the adverse reactions
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Table 4
Clinical manifestation and severity of adverse drug reaction
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