A Prospective Study of Adverse Drug Reactions in 1 Month–12 Years Old Pediatric Patients
Abstract: Adequate controlled
clinical trials in pediatric population, especially in oncology and
vaccinations are still insufficient due to ethical considerations. Certain
conditions in children in general and in Indian children in particular,
suggested the need for Adverse Drug Reaction (ADR) monitoring. Thus this study was
aimed to investigate the incidence of ADRs in pediatric populations. A
prospective spontaneous reporting study was conducted over a period of six
months from October 2012 to March 2013 in pediatric inpatients ward of Bharati
Hospital in Pune. Reported ADRs were assessed for its causality by using WHO causality
assessment scale, and its severity by using Hart wig Severity Scale. A total of
107 suspected ADRs were reported and evaluated from 54 patients, showing an
overall incidence of 4.75%. Incidence rate of ADRs during hospitalization was
4.13%, while ADRs induced hospitalization was 0.62%. The gastrointestinal
system (48.59%) was the most affected, and antibiotics was the most common the
drug class associated to ADRs. In term of causality, 55.14% of the reactions
were classified as possible, while in term of severity, 64.49% were classified
as moderate. Most patients (60.75%) recovered from the incidence. Although the
prevalence and severity of ADRs in pediatrics populations is reported to be higher
than those of in adults, the incidence of ADRs in our study was only 4.75%
which is lower than those of reported in adults, this may due to the
spontaneous reporting system that used in this study.
Author: Asawari Raut, Vijay
Kalrao, Roja Rani, Ravi Kumar
Journal Code: jpfarmasigg150002
