Journal List > Allergy Asthma Respir Dis > v.4(5) > 1059207

TOOLS
Park, Park, Jung, Han, Kim, Lee, Cho, Kim, Yoon, Yu, Kim, and Hong: Pediatric adverse drug reactions collected by an electronic reporting system in a single tertiary university hospital
Original Article

Allergy, Asthma & Respiratory Disease 2016; 4(5): 354-359.

Published online: 30 September 2016

DOI: https://doi.org/10.4168/aard.2016.4.5.354

Pediatric adverse drug reactions collected by an electronic reporting system in a single tertiary university hospital

Geun-Mi Park1, Joo Hyun Park1, Joo Won Jung1, Hye Won Han1, Jae Youn Kim1, Eun Lee2, 3, Hyun-Ju Cho2, 3, Yeongho Kim2, 3, Jisun Yoon2, 3, Jinho Yu2, Tae-Bum Kim4, Soo-Jong Hong2, 3

1Department of Pharmacy, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.

2Department of Pediatrics, Childhood Asthma Atopy Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.

3Environmental Health Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.

4Allergy and Clinical Immunology, Asan Regional Pharmacovigilance Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.

Correspondence to: Soo-Jong Hong. Department of Pediatrics, Childhood Asthma Atopy Center, Environmental Health Center, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Korea. Tel: +82-2-3010-3379, Fax: +82-2-473-3725, sjhong@amc.seoul.kr

Received 2 February 2016       Revised 20 April 2016       Accepted 27 April 2016

© 2016 The Korean Academy of Pediatric Allergy and Respiratory Disease; The Korean Academy of Asthma, Allergy and Clinical Immunology

(open-access):

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

The incidence of adverse drug reactions (ADRs) is increasing. However, studies on the prevalence of ADRs in children are rare. The aim of this study was to investigate the causative drugs and clinical features of ADRs for children in a tertiary university hospital of Korea.

Methods

We retrospectively collected ADRs by a computerized self-reporting system in Asan Medical Center. ADRs of children under the age 18 were collected from January 2005 to August 2015, and we analyzed only ADRs containing current symptoms among total ADR data.

Results

A total of 1,408 ADR cases were reported, There were 764 male (54.3%) and 644 female patients (45.7%), and the mean age was 11.5±5.8 years (range, 0–18 years). Antibiotics (n=479, 34.0%) were the most common causative drugs, followed by tramadol (n=173, 12.3%), nonsteroidal anti-inflammatory agents (NSAIDs) and acetylsalicylic acid (n=103, 7.3%), narcotics (n=91, 6.5%), antineoplastics (n=87, 6.2%), and sedatives (n=82, 5.8%). The most common clinical features were skin manifestations (n=500, 34.4%). Gastrointestinal symptoms (n=435, 29.9%) were the second most common clinical features, followed by neuropsychiatric symptoms (n=155, 10.7%) and respiratory symptoms (n=123, 8.5%). Among antibiotics, glycopeptides (n=110, 23.0%), third-generation cephalosporins (n=83, 17.3%), and penicillin/β-lactamase inhibitors (n=60, 12.7%) were the most frequently reported causative drugs.

Conclusion

Antibiotics were the most reported common causative drugs of ADRs in children, followed by tramadol, NSAID, and narcortics. Compared with adults, the prevalence of contrast medium-induced ADR was lower in children with a higher prevalence of sedative-associated ADR. Greater attention to possible ADRs in children is needed among medical personnel.

Keywords: Adverse drug reaction, Child, Antibiotics, Tramadol, Sedatives

Figures and Tables

Fig. 1

Frequencies of antibiotics that caused adverse drug reactions.

aard-4-354-g001
Table 1

Demographic data of patients included in this analysis

aard-4-354-i001
Characteristic Value
No. of reports 1,408
Male sex 764 (54.3)
Age (yr) 11.5±5.8
 0–1 137 (9.7)
 2–6 221 (15.7)
 7–12 279 (19.8)
 13–18 771 (54.8)

Values are presented as number of reports (%) or mean±standard deviation.

Table 2

Frequency of drug to cause the adverse reactions

aard-4-354-i002
Classification No. (%)
Antibiotics 479 (34.0)
Tramadol 173 (12.3)
NSAIDs and aspirin 103 (7.3)
Narcotics 91 (6.5)
Antineoplastic 87 (6.2)
Sedatives 82 (5.8)
GI regulator 45 (3.2)
Contrast medium 36 (2.6)
Acetaminophen 26 (1.8)
Anticonvulsant 24 (1.7)
Antiulcerants 24 (1.7)
Vitamin 23 (1.6)
Electrolyte, caloric, and water 17 (1.2)
Antitussives 12 (0.9)
Steroids 13 (0.9)
Antihistamine 12 (0.9)
Bronchodilator 12 (0.9)
Anesthetics 12 (0.9)
Vaccines 9 (0.6)
Cardiovascular 6 (0.4)
Topical drug 7 (0.5)
Others 115 (8.2)
Total 1,408 (100)
Table 3

Clinical manifestations and proportion of adverse drug reaction

aard-4-354-i003
Classification Clinical manifestations (No.) No. of reports (%)
Skin Skin eruption (228), urticaria (118), itching (102), angioedema (26), others (26) 500 (34.4)
Gastrointestinal Nausea (246), vomiting (120), diarrhea (45), abdominal pain (20), others(4) 435 (29.9)
Neuropsychiatric Dizziness (87), depression · anxiety (22), headache (16), behavioral disorder (16), mental deterioration (11), insomnia (3) 155 (10.7)
Respiratory Dyspnea (100), chest tightness (11), coughing (6), wheezing (4), rhinorrhea · nasal obstruction (2) 123 (8.5)
Generalized Fever (26), anaphylaxis (19), edema (6), myalgia (3) 54 (3.7)
Cardiovascular Hypotension (22), palpitation·arrhythmia (10), shock (13) 45 (3.1)
Hepatotoxicity Elevated liver enzyme (7), jaundice (1) 8 (0.5)
Hematology Thrombocytopenia (2), pancytopenia (3), neutropenia (1) 6 (0.4)
Renal & urinary Urinary retention (1) 1 (0.1)
Others 128 (8.8)
Table 4

Analysis of adverse events associated with sedatives

aard-4-354-i004
Variable Value
Patient number 82
Age (yr) 5.2±5.1
Male sex 42 (51.2)
Causative drugs
 Midazolam 34 (41.5)
 Chloral hydrate 29 (35.4)
 Ketamine 14 (17.1)
 Others 5 (6.1)
Clinical manifestations
 Respiratory 31 (31.5)
 Gastrointestinal 13 (15.3)
 Skin 10 (11.8)
 Neuropsychiatric 8 (9.4)
 Cardiovascular 6 (7.1)
 Generalized 3 (3.5)
 Others 14 (16.5)

Values are presented as mean±standard deviation or number of patients (%).

References

1. International drug monitoring: the role of national centres. Report of a WHO meeting. World Health Organ Tech Rep Ser. 1972; 498:1–25.
2. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998; 279:1200–1205.
crossref
3. Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley TJ, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ. 2004; 329:15–19.
crossref
4. Bowman L, Carlstedt BC, Black CD. Incidence of adverse drug reactions in adult medical inpatients. Can J Hosp Pharm. 1994; 47:209–216.
5. Lundkvist J, Jönsson B. Pharmacoeconomics of adverse drug reactions. Fundam Clin Pharmacol. 2004; 18:275–280.
crossref
6. Moore TJ, Cohen MR, Furberg CD. Serious adverse drug events reported to the Food and Drug Administration, 1998-2005. Arch Intern Med. 2007; 167:1752–1759.
crossref
7. Demoly P, Bousquet J. Epidemiology of drug allergy. Curr Opin Allergy Clin Immunol. 2001; 1:305–310.
crossref
8. Pirmohamed M, Breckenridge AM, Kitteringham NR, Park BK. Adverse drug reactions. BMJ. 1998; 316:1295–1298.
9. Kim MH, Jung HY, Sohn MK, Kim SE, Lee YW, Park JW, et al. Clinical features of adverse drug reactions in a tertiary care hospital in Korea. Korean J Asthma Allergy Clin Immunol. 2008; 28:35–39.
10. Kim MG, Kang HR, Kim JH, Ju YS, Park SH, Hwang YIl, et al. Analysis of adverse drug reactions collected by an electronic reporting system in a single hospital. Korean J Med. 2009; 77:601–609.
11. Kim JE, Kyun JO, Jin SM, Lee YH, Kim JH, Lee HY, et al. Adverse drug reactions in elderly inpatients: comparison with younger patients. Korean J Asthma Allergy Clin Immunol. 2010; 30:216–221.
12. Choi JH, Shin YS, Suh CH, Nahm DH, Park HS. The frequency of adverse drug reactions in a tertiary care hostpital in Korea. Korean J Med. 2004; 67:290–296.
13. Rew SY, Koh YI, Shin HY, Park SH, Ryu SH, Kim HN, et al. Reporting and clinical features of adverse drug reactions from a single university hospital. Korean J Asthma Allergy Clin Immunol. 2011; 31:184–191.
14. Kos M, Wertheimer AI, Mrhar A. Satisfaction with pharmacotherapy for approved and off-label indications: a Delphi study. Ann Pharmacother. 2005; 39:649–654.
crossref
15. Geum MJ, Park EH, Ko JH, Kim SH, Kim SE, Seok HJ. Case analysis of adverse drug reaction for children in Yonsei University Healthcare System. J Korean Soc Health Syst Pharm. 2011; 28:253–261.
crossref
16. Coté CJ, Karl HW, Notterman DA, Weinberg JA, McCloskey C. Adverse sedation events in pediatrics: analysis of medications used for sedation. Pediatrics. 2000; 106:633–644.
17. Malviya S, Voepel-Lewis T, Prochaska G, Tait AR. Prolonged recovery and delayed side effects of sedation for diagnostic imaging studies in children. Pediatrics. 2000; 105:E42.
crossref
18. Kim HM, Seong JM, Yang BR, Jin XM, Choi NK, Lee J, et al. Analysis of adverse events reporting patterns and signal detection for pediatric patients in the Korean spontaneous reporting data. Korean Soc Pharmacoepidemiol Risk Manage. 2012; 5:40–45.
19. Ferrajolo C, Capuano A, Trifirò G, Moretti U, Rossi F, Santuccio C. Pediatric drug safety surveillance in Italian pharmacovigilance network: an overview of adverse drug reactions in the years 2001 - 2012. Expert Opin Drug Saf. 2014; 13:Suppl 1. S9–S20.
crossref
20. Park GM, Seo JH, Kim HY, Yu J, Hong SJ. Four cases of drug allergy caused by non-steroidal anti-inflammatory drugs in children. Pediatr Allergy Respir Dis. 2011; 21:344–349.
crossref
21. Mirakian R, Ewan PW, Durham SR, Youlten LJ, Dugué P, Friedmann PS, et al. BSACI guidelines for the management of drug allergy. Clin Exp Allergy. 2009; 39:43–61.
crossref
22. Jung JH, Kim JT, Yoo KY. Assessment of pediatric adverse drug reaction reports. J Korean Soc Health Syst Pharm. 2013; 30:108–118.
crossref
TOOLS
ORCID iDs

Soo-Jong Hong
https://orcid.org/http://orcid.org/0000-0003-1409-2113

Similar articles