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Assignment: Off -Label Drug Use in Pediatrics
BACKGROUND INFORMATION
The client is an 8-year-old African American male who arrives at the ER with his mother. He is exhibiting signs of depression.
Client complained of feeling “sad”
Mother reports that teacher said child is withdrawn from peers in class
Mother notes decreased appetite and occasional periods of irritation
Client reached all developmental landmarks at appropriate ages
Physical exam unremarkable
Laboratory studies WNL
Child referred to psychiatry for evaluation
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MENTAL STATUS EXAM
Alert & oriented X 3, speech clear, coherent, goal directed, spontaneous. Self-reported mood is “sad”. Affect somewhat blunted, but child smiled appropriately at various points throughout the clinical interview. He denies visual or auditory hallucinations. No delusional or paranoid thought processes noted. Judgment and insight appear to be age-appropriate. He is not endorsing active suicidal ideation, but does admit that he often thinks about himself being dead and what it would be like to be dead.
You administer the Children\’s Depression Rating Scale, obtaining a score of 30 (indicating significant depression)
Decision 1 Paxil 10 mg after 2 weeks patient returned follow up finding: Client returns to the clinic in four weeks
Reduction in The Children\’s Depression Rating Scale by 5 points overall, but with complaints of nausea, vomiting, and diarrhea
Decision 2 Decrease dose for 7 days then return to previous 10 mg daily
3. Decision point 3 Change to a different SSRI
Rationale: Temporarily decreasing the drug for 7 days and then increasing is an acceptable option- however, if the side effects return with the reinitiation of the dose, you will need to select a different agent as these side effects are unfavorable to the client and may result in refusal to take treatment. Also, continuing to drop medication dose to the subtherapeutic level will do minimal to treat depressive symptoms. Changing to a different SSRI would be the ideal choice as not all SSRIs have the same side effect profile in all clients. It would not be appropriate to increase the dose at this time as it would most likely result in increased intensity of side effects.
Assignment
1. Explain the circumstances under which children should be prescribed drugs for off-label use. Be specific and provide examples.
2. Describe strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence.
3. Include descriptions and names of off-label drugs that require extra care and attention when used in pediatrics.
Appropriate conclusion
Comments / Note