Off-label drug use in a Pediatric Intensive Care Unit

• Published in: Indian journal of pediatrics Vol. 76; no. 11; pp. 1113 - 1118
• Main Authors: Bavdekar, S. B., Sadawarte, Pranjali A., Gogtay, Nithya J., Jain, Surabhi S., Jadhav, Sandhya
• Format: Journal Article
• Language: English
• Published: India Springer-Verlag 01.11.2009; Springer
• Subjects: Biological and medical sciences; Child; Child, Preschool; Drug Prescriptions - statistics & numerical data; General aspects; Gynecology; Hospitals; Humans; India - epidemiology; Infant; Infant, Newborn; Intensive Care Units, Pediatric - statistics & numerical data; Medical sciences; Medicine; Medicine & Public Health; Off-Label Use - statistics & numerical data; Original Article; Pediatrics; Prevalence; Prospective Studies; India; Drug therapy; Drugs prescription; Drug utilization; Drug labeling; Human; Pediatrics; Treatment; Medical prescription; Tropical medicine; Child; Intensive care unit
• ISSN: 0019-5456; 0973-7693
• DOI: 10.1007/s12098-009-0238-3

Objective To determine the extent and nature of off-label drug use in children admitted to a Pediatric Intensive Care Unit (PICU) Methods This prospective exploratory study was conducted in a tertiary care hospital in a metropolitan city in India after obtaining clearance from the institutional ethics committee. Subjects admitted in PICU from February–August 2006 were enrolled in the study. In addition to the demographic data and diagnosis, details of drugs prescribed (name, dose and route and frequency of administration) were obtained from hospital records. British National Formulary 2005 was used to determine if the prescriptions were off-label and if so, they were categorized as off-label for age, indication, dosage or frequency and route of administration. Descriptive statistics was used to determine the proportion of off-label drug use. Fischer’s exact test was used to determine if there was significant difference (P<0.05) in off-label use between patients with multiple system affection and those with single system affection and between those requiring artificial ventilatory support and those not requiring it. Results Three hundred subjects received 2237 analyzable prescriptions. Of these 1579 (70.58%) prescriptions were offlabel in nature. Off-label drug use was prevalent in all age-groups and in all systemic afflictions. The proportion of off-label drug use was not influenced by severity of illness, as judged by involvement of multiple systems or need for ventilatory support. The list of off-label drugs used included old as well as new molecules. Most commonly used drugs in PICU were also the most common off-label drugs. Conclusion Off-label drug use is highly prevalent in PICU settings.