Authors

1 Department of Clinical Pharmacy, Tehran University of Medical Sciences, Tehran, Iran

2 Iranian Adverse Drug Reaction Monitoring Center, Food and Drug Organization, Ministry of Health, Tehran, Iran

3 Department of Clinical Pharmacy, Tehran University of Medical Sciences, Tehran, Iran Pediatrics Center of Excellence, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran

Abstract

Objective: Adverse drug reactions (ADRs) are known as a cause of hospital admission. We 
have carried out a prospective study to characterize and assess the frequency, probability, 
preventability, and severity of ADRs, which lead to hospital admission in children.
Methods: In a prospective observational study, a cohort of children admitted to a tertiary 
pediatric hospital was randomly screened to assess ADR as the cause of admission from June 
2014 to January 2015. ADRs causing admissions were detected based on patients’ records, 
interviewing their parents, and confirmation by medical team. The probability of the ADRs 
was assessed based on WHO criteria and Naranjo tool. The preventability assessment was 
performed using Schumock and Thornton questionnaire.
Findings: Of the 658 evaluated emergency admissions, 27 were caused by an ADR giving 
an incidence of 4.1%. Among ADRs, 37.1% were estimated to be preventable. Antibiotics 
were the most common medication class which caused hospital admission.
Conclusion: Pediatric pharmacotherapy still needs evidence‑based strategies to improve 
child care including education, monitoring, planning for medications after ADR occurrence, 
and implementing preventive measures when applicable.

Keywords

1. Hopf Y, Watson M, Williams D. Adverse‑drug‑reaction 
related admissions to a hospital in Scotland. Pharm World 
Sci 2008;30:854‑62.
2. 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;329:15‑9.
3. van der Hooft CS, Dieleman JP, Siemes C, Aarnoudse AJ, 
Verhamme KM, Stricker BH, et al. Adverse drug 
reaction‑related hospitalisations: A population‑based cohort 
study. Pharmacoepidemiol Drug Saf 2008;17:365‑71.
4. Easton‑Carter KL, Chapman CB, Brien JE. Emergency 
department attendances associated with drug‑related 
problems in paediatrics. J Paediatr Child Health 2003;39:124‑9.
5. Posthumus AA, Alingh CC, Zwaan CC, VanGrootheest KK, 
Hanff LL, Witjes BB, et al. Adverse drug reaction‑related 
admissions in paediatrics, a prospective single‑center study. 
BMJ Open 2012;2:E000934.
6. Langerova P, Vrtal J, Urbanek K. Adverse drug reactions 
causing hospital admissions in childhood: A prospective, 
observational, single‑center study. Basic Clin Pharmacol 
Toxicol 2008;102:408‑11.
7. Gallagher RM, Mason JR, Bird KA, Kirkham JJ, Peak M, 
Williamson PR, et al. Adverse drug reactions causing 
admission to a paediatric hospital. PLoS One 2012;7:e50127.
8. Impicciatore P, Choonara I, Clarkson A, Provasi D, 
Pandolfini C, Bonati M. Incidence of adverse drug reactions 
in paediatric in/out‑patients: A systematic review and 
meta‑analysis of prospective studies. Br J Clin Pharmacol 
2001;52:77‑83.
9. Smyth RM, Gargon E, Kirkham J, Cresswell L, Golder S, 
Smyth R, et al. Adverse drug reactions in children – A 
systematic review. PLoS One 2012;7:e24061.
10. Edwards IR, Aronson JK. Adverse drug reactions: Definitions, 
diagnosis, and management. Lancet 2000;356:1255‑9.
11. Gallagher RM, Bird KA, Mason JR, Peak M, Williamson PR, 
Nunn AJ, et al. Adverse drug reactions causing admission 
to a paediatric hospital: A pilot study. J Clin Pharm Ther 
2011;36:194‑9.
12. World Health Organization. Safety Monitoring of Medical 
Products, Guidelines for Setting up and Running a 
Pharmacovigilance Centre. Uppsala Monitoring Centre: 
World Health Organization; 2000.
13. Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, 
et al. A method for estimating the probability of adverse drug 
reactions. Clin Pharmacol Ther 1981;30:239‑45.
14. Schumock GT, Thornton JP. Focusing on the preventability of 
adverse drug reactions. Hosp Pharm 1992;27:538.
15. Easton KL, Chapman CB, Brien JA. Frequency and 
characteristics of hospital admissions associated with 
drug‑related problems in paediatrics. Br J Clin Pharmacol 
2004;57:611‑5.
16. Martínez‑MirI, García‑López M, Palop V, FerrerJM, Rubio E, 
Morales‑Olivas FJ. A prospective study of adverse drug 
reactions in hospitalized children. Br J Clin Pharmacol 
1999;47:681‑8.
17. BlakeKV, ZaccariaC, DomergueF, MacheEL, Saint‑RaymondA, 
Hidalgo‑Simon A. Comparison between paediatric and adult 
suspected adverse drug reactions reported to the European 
medicines agency: Implications for pharmacovigilance. 
Pediatr Drugs 2014;16:309‑19.
18. Thomas DW, Greer FR, American Academy of Pediatrics 
Committee on Nutrition, American Academy of Pediatrics 
Section on Gastroenterology, Hepatology, and Nutrition. 
Probiotics and prebiotics in pediatrics. Pediatrics 
2010;126:1217‑31