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Off-label drug use in a Pediatric Intensive Care Unit
S B Bavdekar1, Pranjali A Sadawarte, Nithya J Gogtay
1Department of Pediatrics, Seth GS Medical College & KEM Hospital, Acharya Donde Road, Parel, Mumbai, India. drsbavdekar@vsnl.com
Insights
Off-label drug use is common in Pediatric Intensive Care Units (PICUs), with over 70% of prescriptions being off-label. This practice spans all age groups and conditions, unaffected by illness severity.
Area of Science:
- Pediatric Pharmacology
- Critical Care Medicine
- Drug Utilization Studies
Background:
- Pediatric Intensive Care Units (PICUs) often manage critically ill children with complex conditions.
- Limited availability of evidence-based, approved medications for pediatric populations necessitates off-label drug use.
- Understanding the patterns of off-label prescribing is crucial for patient safety and optimizing pharmacotherapy in PICUs.
Purpose of the Study:
- To investigate the prevalence and characteristics of off-label medication use in a Pediatric Intensive Care Unit (PICU).
- To categorize the types of off-label prescribing (age, indication, dose, route, frequency).
- To explore potential associations between off-label drug use and patient factors like illness severity.
Main Methods:
- Prospective observational study conducted in a tertiary care Indian hospital.
- Data collected from 300 children admitted to the PICU over a six-month period.
- Prescriptions analyzed against the British National Formulary 2005 for off-label status, categorized by deviation from approved use.
Main Results:
- A total of 2237 prescriptions were analyzed, with 1579 (70.58%) identified as off-label.
- Off-label drug use was widespread across all age groups and systemic conditions.
- The extent of off-label prescribing was not significantly influenced by illness severity (multiple systems affected or need for ventilatory support).
Conclusions:
- Off-label drug use is highly prevalent in Pediatric Intensive Care Unit (PICU) settings.
- Commonly used medications in the PICU were frequently prescribed off-label.
- Further research and guidelines are needed to address the high rate of off-label prescribing in pediatric critical care.
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.
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