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Abstract

Off-label use is defined as the use of pharmaceutical drugs for an unapproved indication or unapproved age group, dose, dosage or route of administration. An off-label use provides the best intervention for the patient when medical evidence justifies its use, but this can also be harmful due to the increased risk of adverse drug reactions when lacking a solid evidentiary basis. Hence, the aim was to assess the use of off-label drugs, observe and document the ADRs, and to find the medical evidence for the same. An observational study was conducted in PSG hospitals from January 2017-September 2017 which included patients prescribed with at least one drug for their medical condition. Patient's information was collected from the medical records and was referenced against the FDA label. Of the total 1646 prescriptions, 54.7% of prescriptions were off-label. Of the total of 10430 medications, 10.40% were off-label. The most common type of off-label drug use was an unapproved indication (74%) followed by unapproved drug (24%). Around 80% of the off-label drugs had high evidence. The number of off-label drugs increases with an increase in disease conditions of the patient. 10% adverse drug reactions were reported for off-label drugs whose incidence was higher with a decrease in evidence. The use of off-label drugs is found to be high in the tertiary care hospital, the primary reason being the lack of an on-label alternative. There is an increased risk of ADRs related to off-label drug use, hence continuous monitoring of off-label drugs is essential.