Off-Label Medicine Use in Pediatric Inpatients: A Prospective Observational Study at a Tertiary Care Hospital in India

الملخص EN

Background.

In the absence of standard pediatric prescribing information, clinicians often use medicines in an off-label way.

Many studies have been published across the globe reporting different rates of off-label use.

There is currently no study based on Indian drug formulary.

Methods.

The prospective observational study included pediatric patients in ages between 0 and 12 years admitted in a tertiary care hospital.

Off-label use was assessed using the National Formulary of India (NFI).

Predictors of off-label use were determined by logistic regression.

Results.

Of the 1645 medications prescribed, 1152 (70%) were off-label based on 14 possible off-label categories.

Off-label medicines were mainly due to dose difference and use in restricted age limits as indicated in NFI.

Respiratory medicines (82%), anti-infectives (73%), and nervous system medicines (53%) had higher off-label use.

Important predictors of off-label prescribing were pediatric patients in age of 0 to 2 years (OR 1.68, 95% CI; P < 0.001 ) and hospital stay of six to 10 days (OR 1.91, 95% CI; P < 0.001 ).

Conclusion.

Off-label prescribing is common among pediatric patients.

There is need to generate more quality data on the safety and efficacy of off-label medicines to rationalize pediatric pharmacotherapy.