Circumstances under which children should be prescribed drugs for off-label use.
Explain the circumstances under which children should be prescribed drugs for off-label use. Be specific and provide examples. Describe strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence. Include descriptions and names of off-label drugs that require extra care and attention when used in pediatrics.
The unapproved use of approved drugs, also called off-label use, with children is quite common. This is because pediatric dosage guidelines are typically unavailable, since very few drugs have been specifically researched and tested with children.
When treating children, prescribers often adjust dosages approved for adults to accommodate a child’s weight. However, children are not just “smaller” adults. Adults and children process and respond to drugs differently in their absorption, distribution, metabolism, and excretion.
Children even respond differently during stages from infancy to adolescence. This poses potential safety concerns when prescribing drugs to pediatric patients. As an advanced practice nurse, you have to be aware of safety implications of the off-label use of drugs with this patient group.
Sample Answer
Off-Label Drug Use in Children: Balancing Necessity with Safety
While off-label drug use is common in pediatrics, it should be approached with caution and only under specific circumstances:
When Off-Label Use Might Be Necessary:
- No approved alternative: When no FDA-approved drug exists for a child’s specific condition or symptoms.
- Limited evidence-based guidelines: For rare diseases or complex conditions lacking sufficient research in children.
- Failure of approved therapy: When standard treatments haven’t yielded desired results.
- Individualized benefit outweighs potential risks: When the potential benefits for a specific child outweigh the known risks of off-label use, considering age, medical history, and individual factors.
Examples of Off-Label Drugs in Pediatrics: