BACKGROUNDDrug therapy in the neonatal age group is not always supported by systematic clinical testing. Organ immaturity and consequently difficulties adapting to extra-maternal life are reasons for preterm neonates being often multi-morbid and in need of intensive care. Consequently, they are exposed to high number of drugs, putting them at a higher risk of adverse drug reactions. This study gives an insight to the extent of usage and nature of off-label drug use among preterm infants admitted in Neonatal Intensive Care Unit (NICU) attached to a tertiary care hospital. MATERIALS AND METHODSThis cross-sectional study was conducted over a six-month period (Aug. 2015 -Jan. 2016) in a Level III NICU attached to a Medical College in Southern India. All inborn and outborn Preterm infants admitted in NICU, during the study period were included in the study. Drugs prescribed were categorised based on World Health Organization Anatomical Therapeutic Chemical (WHO-ATC) Classification System. 9 Data collected was evaluated for off-label category of drugs using the National Formulary of India (NFI, 4 th edition, 2011) RESULTSThe study included a total of 154 Preterm infants, with majority of the study population in the late Preterm (>34 weeks gestational age) group accounting for 66.2% (n=102). A total of 1426 medications were administered to Preterm infants during the hospitalisation of which 1083 (75.9%) medicines were prescribed in off-label manner. The most common cause of off-label prescribing was for age (55%). The extent of off-label prescribing was highest (78%) in very Preterm 28-34 weeks gestational age group, followed by 76.2% in late Preterm >34 weeks gestational age group. Of the 154 Preterm infants included in the study, 150 (97.4%) received at least one off-label medication and 100% of the Extreme Preterm group infants received one or more off-label medicines. Among the total off-label medicines (n= 1083) prescribed, 58% was accounted by Anti-infectives for Systemic use group of drug. CONCLUSIONOff-label prescribing is a reality and will not end soon. Implementing evidence-based approach can significantly improve rationality of neonatal pharmacotherapy.

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Background: Neonates and in particular preterm neonates belongs to the most vulnerable population. A neonatal intensive Care Unit (NICU) is a highly specialized unit that provides high quality skilled care to critically ill new newborn, premature or low birth weight babies. Apart from facilities for continuous clinical and biochemical monitoring, NICU management involves the use of wide range of medications. Irrational prescription of drug is common in clinical practice, important reason being lack of knowledge about drug prescription. Developing countries have limited funds available for health care and drugs so it becomes very important to prescribe drugs rationally. The present study was done to find out the drug utilization pattern and improve the rational use which aids in the improvement of neonatal care.  Methods: The study was retrospective study in NICU of tertiary care hospital attached to MIMS, Mandya for a duration of 6 months. Data extraction sheet were used to collect the information regarding demographic details, maternal and delivery details, indication for admission, final diagnosis and medications administered. Data collected were evaluated for the category of prescribed, based on World Health Organization Anatomical Therapeutic Committee (WHO classification system and were analyzed using SPSS. WHO drug utilization core indicators were also evaluated.Results: Among 400 neonates admitted in NICU during the study period, 53.7% were males and 46.2% were females. There were 29.7% preterm born neonates. The maximum number of neonates were admitted in early neonatal period (87.25%). Neonatal sepsis (37.9%) and Birth asphyxia (11.6%) were the most common indications for admission. The total number of drugs prescribed was 1428 and the average number of drugs per neonate was 3.57. Preterm (<37weeks) and low birth weight (<2.5Kg) were exposed to significantly higher number of drugs. The most frequently prescribed therapeutic class of drugs was anti-infectives (60.36%), followed by drugs of central nervous system (7. 84%). Among the anti-infectives, the most commonly prescribed drugs were Ampicillin (59%), followed by gentamycin (42.5%). High end antibiotics like carbapenems, colistin’s and linezolid were used in less than 5% of cases.Conclusions: Drug use in neonates should be minimal and focus on the importance of therapeutic treatment guidelines establishment in hospital to control the over usage of antibiotics.

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