ABSTRACT
Background: Adverse drug reactions (ADRs) are an important cause of morbidity and mortality across the world and contribute to a significant economic burden on healthcare resources and community. In children, monitoring ADRs is essential as adequate clinical trials are lacking in this group. So, this study was undertaken to assess the ADR pattern in a paediatric population in a tertiary care hospital.Methods: A cross sectional, retrospective study was done at ADR monitoring centre (AMC) for a period of 3 years in a tertiary care hospital. All the ADRs reported by the Department of Paediatrics to AMC were collected and analyzed for age group affected, demographic profile, ADR pattern, drug group, systems affected, causality and severity of the ADR.Results: During the study period, a total of 102 ADRs were reported to the AMC from the paediatric department. Out of 102 ADRs reported, males represented 60.8% and females represented 39.2%. Maximum number of ADRs were seen in the age group of 1-5 years (43.3%). Most common ADR reported was maculopapular rash (27.5%) followed by diarrhoea (14.7%). The most common drug class causing ADRs are antibiotics (36.3%) followed by anticonvulsants (18.6%). Vaccines contributed to 14.7% of all reported ADRs. Majority of the ADRs were of probable (70.6%) causality and moderate (52%) in severity.Conclusions: ADRs were reported more among under 5 years of age and antibiotics were the common implicated causative agents. Most of the reactions were of moderate severity. Information acquired through ADR reporting may be useful in identifying and minimizing preventable ADRs and augmenting the knowledge of the prescribers to deal with ADRs more efficiently.
ABSTRACT
Introduction: Neonatologists face a perpetual challenge in managing neonatal septicaemia due to changing patterns of the microbial flora and their antibiotic sensitivity. The present study was designed to evaluate the clinical spectrum, bacteriological profile, antibiotic sensitivity patterns in neonates with suspected septicaemia in a tertiary care teaching hospital. Material and Methods: This prospective observational study was carried out in neonatal intensive care unit for a period of nine months. All the neonates with suspected septicaemia, were evaluated by sepsis screen (C- reactive protein). C-reactive protein positive neonates were subjected to blood culture for isolation of microorganisms. Antibiotic sensitivity testing was done with disc diffusion method. The data was analyzed using descriptive statistics. Results: Among 519 neonates, blood culture was positive in 183 (35.2%). Most of the neonates presented with early onset sepsis(65%), were preterm(59%) and of low birth weight (58.5%). Major clinical presentation was respiratory distress (31.2%). Gram negative bacteria were frequently isolated (68.3%). Most common isolates were Klebsiella pneumonia (34.70%) and staphylococcus aureus (21.8%) respectively. Gram negative organisms were sensitive to imipenem, followed by piperacillin tazobactam and amikacin. Gram positive organisms showed good sensitivity to vancomycin, teicoplanin and imipenem. High resistance was observed to ampicillin and ceftriaxone in both gram positive and gram negative organisms. Conclusions: Preterm and low birth weight neonates were more susceptible to neonatal sepsis. Gram negative organisms were frequently isolated. The present study would suggest rational use of empirical antibiotic therapy and to review the antibiotic policy periodically basing on the microbial flora detected in their region time to time.