Background: Pediatric population is vulnerable to the development of adverse drug events (ADEs). Despite that, ADEs are less reported through passive surveillance methods. Less data are available to establish the effectiveness of active surveillance methods.
Aims and Objectives: The aims of this study were to analyze the ADEs collected through active surveillance in pediatric patients.
Materials and Methods: Prospective and observational study of 1 year was conducted in pediatric wards of Shree Krishna Hospital, Anand. The patients of age ranging from 1 month to 18 years (and caregivers) were asked about the development of new symptom which was unintended and harmful after the administration of medicines. The patients who developed the ADEs after admission or who were admitted with ADEs were included in the study. Data were entered into Microsoft Excel for descriptive analysis.
Results: Out of total 550 admissions, 35 ADEs (6.36%) were captured in 29 patients through active surveillance, whereas during the previous 4 years 17 ADEs (0.35%), out of 4846 admissions were reported through passive reporting. Out of 35 ADEs, the most common suspected drug group was antimicrobial agents (12, 34.29%) and the most common system affected was skin (15, 42.86%). Causality assessment by the World Health Organization – Uppsala Monitoring Center scale suggested that 62.86% ADEs were of possible type and by Naranjo’s scale 68.57% ADEs were of possible type. Based on the Hartwig and Siegel adverse drug reaction severity assessment scale, 71.43% ADEs were mild and 77.14% ADEs were of not preventable category by modified Schumock and Thornton criteria.
Conclusion: Active surveillance method is better at identifying ADEs than passive reporting. Strengthening of pharmacovigilance systems will help in the medication safety in the long run.
Key words: Active Surveillance; Adverse Drug Event; Adverse Drug Reaction; Pediatrics
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