OFF-LABEL DRUG USE IN PEDIATRICS And Case Study Analysis
2.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.
Sample Answer
Off-label drug use is the practice of prescribing a drug for a purpose other than what it is approved for by the Food and Drug Administration (FDA). This is a common practice in pediatrics, as there are many drugs that have not been specifically approved for use in children.
There are a number of circumstances under which children may be prescribed drugs for off-label use. These include:
- When there is no approved drug for the child’s condition. This is the most common reason for off-label drug use in children. For example, there is no approved drug for the treatment of pediatric epilepsy. In these cases, doctors may prescribe drugs that are approved for use in adults, but that have not been specifically studied in children.