Evaluation of Adverse Drug Reactions in Paediatric Patients: A Retrospective Study in Turkish Hospital.

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Khan Z., Karataş Y., Kıroğlu O.

Frontiers in pharmacology, vol.12, pp.786182, 2021 (SCI-Expanded) identifier identifier identifier

  • Publication Type: Article / Article
  • Volume: 12
  • Publication Date: 2021
  • Doi Number: 10.3389/fphar.2021.786182
  • Journal Name: Frontiers in pharmacology
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus, BIOSIS, CAB Abstracts, EMBASE, Veterinary Science Database, Directory of Open Access Journals
  • Page Numbers: pp.786182
  • Keywords: adverse drug reactions, children, paediatric, antibiotics, patient safety, Turkey, INDUCED LIVER-INJURY, HEALTH-CARE PROFESSIONALS, CAUSALITY ASSESSMENT, CHILDREN, SAFETY, VANCOMYCIN, ADMISSIONS, KNOWLEDGE
  • Çukurova University Affiliated: Yes


Drug safety in paediatric patients is a serious public health concern around the world. The

paediatric patients are more prone to adverse drug reactions (ADRs) than adults.

Moreover, there is a scarcity of information about ADRs in paediatric patients. This

study was conducted to determine the frequency, causality, severity, preventability of

paediatric patients’ ADRs reported in a tertiary care hospital in Adana, Turkey. A

retrospective study was conducted on all spontaneously reported ADRs between

January 01, 2020, to July 30, 2021, in paediatric patients. The ADRs reports were

evaluated in terms of gender, age, ADR characteristics, suspected drugs and reporting

source. All included ADRs reports were characterized according to the Naranjo Algorithm/

World Health Organization (WHO) causality scales, Hartwig/Siegel and Common

Terminology Criteria for Adverse Events (CTCAE) severity scales, the modified

Schoumock and Thornton preventability scale and hospital pharmacovigilance center

criteria for seriousness. Therapeutic groups were also coded using the WHO-Anatomical

Therapeutic and Chemical (ATC) classification. During the study period, 8,912 paediatric

patients who were admitted had 16 ADRs with 1.7 ADRs/1,000 admissions. The majority

of ADRs were found in infants (31.2%) and children (56.2%) as compared to adolescents

(12.5%). ADRs were observed more in females (81.2%) than males. Skin (62.5%) was the

most affected organ due to the ADRs, and maculopapular rash and erythema multiforme

were the most commonly reported symptoms. Most ADRs were probable/likely (93.7%),

severe (50%), preventable or probably preventable (43.7%) and serious (37.5%).

Antibiotics (93.7%) were found to be the most common cause of ADRs in paediatric

patients. The majority of ADRs were associated with vancomycin (68.7%). Most of the

ADRs were reported by a medical doctor in this study. This small sample size study

highlights significant problems of ADRs in paediatric patients, mainly caused by antibiotics

and with a majority of ADRs manifest as skin reactions. Furthermore, a high proportion of

the identified ADRs were found to be preventable. More focused efforts are needed at the

national level to avoid preventable ADRs in hospitals. Monitoring and management of

ADRs and future studies would be beneficial for better patient care and safety.

Keywords: adverse drug reactions, children, paediatric, antibiotics, patient safety, Turkey