Adverse Drug Reactions in Hospitalized Pediatric Patients: A Prospective Observational Study

• Published in: Indian journal of pediatrics Vol. 83; no. 5; pp. 414 - 419
• Main Authors: Kurian, J., Mathew, J., Sowjanya, K., Chaitanya, K. R. K., Ramesh, M., Sebastian, J., Narayanappa, D.
• Format: Journal Article
• Language: English
• Published: New Delhi Springer India 01.05.2016
• Subjects: Adolescent; Age Factors; Child, Preschool; Drug Monitoring - methods; Drug Monitoring - statistics & numerical data; Drug-Related Side Effects and Adverse Reactions - diagnosis; Drug-Related Side Effects and Adverse Reactions - epidemiology; Drug-Related Side Effects and Adverse Reactions - etiology; Female; Gynecology; Hospitalization - statistics & numerical data; Humans; Incidence; India - epidemiology; Infant, Newborn; Male; Medicine; Medicine & Public Health; Original Article; Pediatrics; Pediatrics - methods; Pediatrics - statistics & numerical data; Pharmacovigilance; Polypharmacy; Risk Factors; Severity of Illness Index; Sex Factors; Tertiary Care Centers - statistics & numerical data; Pediatrics; Adverse drug reactions; Pharmacovigilance; ADR monitoring
• ISSN: 0019-5456; 0973-7693
• DOI: 10.1007/s12098-015-2002-1

Objectives To determine the incidence, pattern, causality, preventability, severity and predictors of adverse drug reactions (ADRs) in pediatric population. Methods It was a prospective, observational study that included patients of either sex, of any age treated in the pediatric wards of a tertiary care hospital. Study patients were followed throughout their hospital stay. Whenever an ADR was detected, all the required data was collected and analyzed. Data was analyzed for incidence, causality (by using WHO Probability scale and Naranjo’s algorithm), preventability (by using Modified Shumock and Thornton scale), severity (by using Modified Hartwig and Siegel scale) and predictors of ADRs. Results Of the 1775 children admitted in the pediatrics ward, 1082 patients met study criteria and were enrolled into the study. A total of 64 ADRs were identified from 54 patients. The incidence of ADRs was 4.99 %. Male patients experienced majority (68.52 %) of ADRs. Drugs most commonly implicated in ADRs were amoxicillin + clavulanate (21.87 %) followed by ceftriaxone (20.31 %). Most (51.56 %) of the ADRs reported belonged to the system organ class, gastrointestinal system disorders. Among the ADRs reported, 82.85 % of ADRs were mild. Majority (87.5 %) of the ADRs were of ‘probable’ causality category and 96.9 % were not preventable. There was a significant association between occurrence of ADRs and the use of ≥4 number of medications, age (infants) and gender (male). Conclusions Among the pediatric population, infants, male gender and those receiving ≥4 number of medications are at risk of developing ADRs. Constant monitoring is required to address the safety issue in pediatric population especially in infants and patients receiving ≥4 drugs.