Background: Globally, pharmacovigilance, rationality of drug prescription studies, and adverse drug reaction (ADR) in children affected with ailments are an understudied topic. Children are a vulnerable age group and reports suggest that over 10% of hospitalized have adverse reactions to therapy and up to 2.9% of all hospital admissions are the consequence of ADRs. In lieu of these observations, the present study was undertaken in a tertiary care hospital to ascertain the bad prescribing habits and ADR in children. Methodology: This was a prospective study and was carried out in the department of pediatrics at a tertiary care hospital for 6 months. The prescription orders of the children on medical treatment for various common ailments were analyzed. The drug prescribing pattern, safety profile of the drug/s alone and in combination was analyzed in accordance with the standard pharmacovigilance method. Results: In the study, a total number of 212 drugs were prescribed for 646 study participants. Most of the study participants were male child, and respiratory infection was the prevalent ailment affecting the children during the study period. With regard to the drug prescription, the average number of drugs per prescription was 3.96. Drugs prescribed by generic name were 6.9%, while 97.21% of the drugs prescribed were observed to be essential for the medical condition. Among the classes of drugs prescribed, antipyretics and antibiotics were the major classes of drugs administered in children admitted in inpatients facility, while among the outpatients (OPs), respiratory drugs and antipyretics were the most common prescribed drugs. Most importantly, polypharmacy was common in inpatients compared to OPs and also that 5.1% had some form of ADR. Conclusion: The present study showed rational prescribing pattern but poor standard pharmacovigilance technique.
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