OBJECTIVES:

Explorations on drug usage in pediatric age group have been rare. Most of the information on drug use pattern reflects the brick models of drug usage in adults. This study aimed to determine the prevalence of Off-Label (OL) and Unlicensed (UL) drug use prescribing in Neonatal Intensive Care Unit (NICU).

METHODS:

A hospital based prospective observational study conducted in NICU at a tertiary care setting for a period of 6 months. The data regarding drug use was compared using National Formulary of India (NFI), European Summary of Product Characteristics (SPC) classification system and Neofax.

RESULTS:

A total of 207 prescriptions were administrated to 70 patients. The average number of drugs prescribed per patient was found to be 2.95. 37 (52.9%) patients had length of NICU stay less than one week and 33 (47.1%) patients had more than one week. According to NFI, 12.07% and 17.39% of drugs prescribed were found to be OL and UL respectively. 7.72% of drugs were found to be OL and 12.07% of drugs were found to be UL according to SPC. Neofax showed 15.45% of drugs as OL and no UL drugs. A significant difference was seen among the guidelines used to identify the OL and UL drugs ( χ²- 12.78, P<0.05). Linear correlation analysis showed a positive association between duration of NICU stay and the number of OL prescriptions (R-0.402; P<0.05).

CONCLUSIONS :

The present study indicates that OL and UL drugs are frequently prescribed in NICU, particularly in vulnerable patients. There is a need to establish standard guidelines due to significant variations among the existing ones. Hence, it is necessary to move forward on clinical research to homogenize the existing data about neonatology drugs and evaluate safety and efficacy of OL and/or UL drugs use in neonates.