Background: The treatment of pediatric patients with drugs in hospitals is being impeded by a shortage in the availability of licensed drugs in an appropriate formulation. Aim of this study is to assess the extent of use of drugs that are not licensed (unlicensed) and drugs that are used outside the terms of the product license (off-label).
Material and Methods: A prospective study was conducted among 210 pediatric patients attending outpatient and inpatients (ward and pediatric intensive care unit) at tertiary care teaching hospital. Demographic data and complete prescription were noted in the predesigned case record form (CRF). Drugs were classified off-label and unlicensed by using National Formulary of India (NFI). Off-label drugs were classified in regards to their indications by using Anatomical Therapeutic Chemical (ATC) Classification. The proportion was compared using chi-square test for statistical analysis.
Results: Out of 1053 drugs, prescribed (42.5%) were off-label drugs and (13.7%) were unlicensed drugs respectively. There was no significant result difference (p>0.05) when the proportion of drug prescribed for outpatients and inpatients. The highest proportion of off-label and unlicensed drugs were prescribed among 0-2 years. Respiratory drug (58.7%) and anti-infective (57.1%) had higher off-label use. The most common reason for off-label use of drugs was dosage of drugs.
Conclusion: This study shows high level of prevalence of prescribing off-label and unlicensed drugs outpatients and among 0-2 years hence it is recommended to generate more quality data on the safety and efficacy of off-label and unlicensed drugs to rationalize paediatric pharmacotherapy.
Unlicensed drug, Off-label drug, Prescription, Pediatric patient