DETECTING AND ANALYZING ADVERSE DRUG REACTIONS IN HOSPITALIZED PEDIATRICS THROUGH INTENSIVE PHARMACOVIGILANCE PROGRAMME TO IMPROVE DRUG SAFETY

Purushothama Reddy K.*, Dr. Rajesh Asija, Dr. M. Purushothaman and Dr. S. Arshiya Banu

ABSTRACT

Background: Adverse Drug Reactions (ADRs) are the harmful, accidental and unwanted effect of a drug which occurs at the dosages used in humans for prophylaxis, diagnosis or therapy. The pediatric population is one of the most vulnerable groups to ADRs. The WHO Global Individual Case Safety Report (ICSR) database (VigiBase®) reported that the rate of ADRs in 7.7% in children was seen from 0 to 17 years. The aim of this study was to detect and analyze Adverse Drug Reactions (ADRs) in hospitalized pediatric patients through the Intensive Pharmacovigilance programme (IPvP) to improve the drug safety. Methods: A prospective cross-sectional study was performed in the pediatric hospital in Nellore in order to assess the hospitalized children from 1 day to 18 years old. Based on the inclusion criteria patients were enrolled. Results: From a total of 1083 hospitalized patients, 19 ADR’s were recorded. The average age of patients in years was 7.2 (±5.9). The causality assessment in this study showed that most of the ADRs were probable (68.4 %) and 4 certain (8.2 %). The most severe ADR’s found were hemolysis and toxic epidermal necrolysis. Conclusions: IPvP was an effective tool for ADR prevention, detection, and evaluation of the treatment in hospitalized patients. The intensive monitoring approach in pharmacovigilance amplifies ADR detection and this translates into the improvement of drug safety in children.

Keywords: Adverse drug reaction, Intensive pharmacovigilance Programme, Drug safety.