Use of off-label drugs in the neonatal intensive care unit in India

Background: Off-label use of drugs is widespread in pediatrics and almost all neonates hospitalized in NICU are affected by the use of off-label drugs regardless of gestational age and birth weight. This is because of the lack of regulation for medications in the neonatal population and the delays in updating drug instructions. This is mainly due to the ethical difficulty in the research and difficulties in conducting clinical trials in this vulnerable population. Hence, the study was planned to assess the extent of the use of off-label drugs in the NICU. Methods: An observational study was carried out in the NICU of a tertiary care center from May 2021 to Oct 2022 and case records of neonates admitted to the NICU were evaluated. Results: Among 1745 drug prescriptions in 360 neonates, 1208 (69.22%) were off-label. Anti-infectives were the most commonly used off-label class of drug, Piperacillin+tazobactam was the most commonly used off-label drug and most common reason for off-label prescriptions was indication and administration. It was found that 79.44% of neonates received at least one off-label drug. Conclusions: Off-label use of drugs, specifically anti-infective drugs, is common in NICUs of India as in other countries. So, more research should be done to generate evidence-based guidelines for the rational use of drugs in neonates

Empyema thoracis in children: Still a challenge in developing countries

Background: To evaluate the effectiveness of surgical intervention in managing empyema thoracis in children. Patients and Methods: A total of 70 patients aged 1-14 years diagnosed to have empyema thoracis and who underwent tube thoracostomy from January 2010 to December 2013 were studied. All patients of which 12 patients needed decortication. Results: The mean age of the study group was 5.44 years and 48.6% were male and 51.4% were female. The most common symptoms at admission were fever (90%), dyspnoea (73%), cough (70%) and chest pain (23%). Pleural fluid cultures were sterile in 60% of patients. The most frequently identified micro-organisms was Staphylococcus aureus (34.2%). Treatment with chest tube drainage was successful in 55 (78.6%) patients. Three patients got expired. Twelve patients had decortications, all of which were successful. The lung re-expansion time was 8.00 ± 1.68 days (range: 5-13 days) in those patients in whom chest tube drainage was successful, whereas it was 7.50 ± 2.623 days (range: 4-14 days) in patients in whom decortication was done. The post-procedure stay was 10.00 ± 1.809 days (range: 7-15 days) in patients with successful chest tube drainage and 9.5 ± 2.902 days (range: 6-17 days) in case of decortication cases. Conclusion: Tube thoracostomy should be done in all cases of empyema thoracis regardless of stage, as this leads to reduction in septic load. Decision of decortication should be taken without any delay