Off-Label Drug Use in Pediatrics

To Prepare:

• Review the interactive media piece in this week’s Resources and reflect on the types of drugs used to treat pediatric patients with mood disorders.
• Reflect on situations in which children should be prescribed drugs for off-label use.
• Think about strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence. Consider specific off-label drugs that you think require extra care and attention when used in pediatrics.

Interactive media piece:

Therapy for Pediatric Clients with Mood Disorders
An African American Child Suffering from Depression

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 Mother reports that teacher said child is withdrawn from peers in class.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.

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)

RESOURCES

§ Poznanski, E., & Mokros, H. (1996). Child Depression Rating Scale–Revised. Los Angeles, CA: Western Psychological Services.

Decision Point One

Select what you should do:

Begin Zoloft 25 mg orally daily

Begin Paxil 10 mg orally daily

Begin Wellbutrin 75 mg orally BID

Decision Point One

Begin Zoloft 25 mg orally daily

RESULTS OF DECISION POINT ONE

Client returns to clinic in four weeks

No change in depressive symptoms at all

Decision Point Two

Select what you should do next:

Increase dose to 37.5 mg orally daily

Increase dose to 50 mg orally daily

Change to Prozac 10 mg orally daily

Decision Point Two

Increase dose to 50 mg orally daily

RESULTS OF DECISION POINT TWO

Client returns to clinic in four weeks

Depressive symptoms decrease by 50%. Cleint tolerating well

Decision Point Three

Select what you should do next:

Maintain current dose

Increase to 75 mg orally daily

Change to a SNRI

Decision Point Three

Maintain current dose

Guidance to Student

At this point, sufficient symptom reduction has been achieved. This is considered a “response” to therapy. Can continue with current dose for additional 4 week to see if any further reductions in depressive symptoms are noted. An increase in dose may be warranted since this is not “full” remission- Discuss pros/cons of increasing drug dose with client at this time and empower the client to be part of the decision. There is no indication that the drug therapy should be changed to an SNRI at this point as the client is clearly responding to this therapy.

Write a 1-1.5page narrative in APA format that addresses the following:

• 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.

• Criteria	Ratings	Pts
  This criterion is linked to a Learning OutcomeExplain the circumstances under which children should be prescribed drugs for off-label use. Be specific and provide examples.	40 to >35.5 ptsExcellentThe response accurately and thoroughly explains in detail the circumstances under which children should be prescribed drugs for off-label use. … The response includes accurate and specific examples that fully support the explanation provided. 35.5 to >31.6 ptsGoodThe response accurately explains the circumstances under which children should be prescribed drugs for off-label use. … The response includes accurate examples that support the explanation provided. 31.6 to >27.6 ptsFairThe response inaccurately or vaguely explains the circumstances under which children should be prescribed drugs for off-label use. … The response includes inaccurate or vague examples that may or may not support the explanation provided. 27.6 to >0 ptsPoorThe response inaccurately and vaguely explains the circumstances under which children should be prescribed drugs for off-label use, or is missing. … The response includes inaccurate and vague examples that do not support the explanation provided, or is missing.	40 pts
  This criterion is linked to a Learning OutcomeExplain strategies to making off-label use and dosage of drugs safer for children from infancy to adolescence and descriptions and names of off-label drugs that require extra care and attention when used in pediatrics. Be specific.	45 to >40.05 ptsExcellentThe response accurately and clearly describes in detail strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence. … The response includes accurate, complete, and detailed descriptions and names of off-label drugs that require extra care and attention when used in pediatrics. 40.05 to >35.55 ptsGoodThe response accurately describes strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence. … The response includes accurate descriptions and names of off-label drugs that require extra care and attention when used in pediatrics. 35.55 to >31.05 ptsFairThe response inaccurately or vaguely describes strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence. … The response includes inaccurate or vague descriptions and names of off-label drugs that require extra care and attention when used in pediatrics. 31.05 to >0 ptsPoorThe response inaccurately and vaguely describes strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence, or is missing. … The response includes inaccurate and vague or incomplete descriptions and names of off-label drugs that require extra care and attention when used in pediatrics, or is missing.	45 pts
  This criterion is linked to a Learning OutcomeWritten Expression and Formatting – Paragraph Development and Organization: Paragraphs make clear points that support well developed ideas, flow logically, and demonstrate continuity of ideas. Sentences are carefully focused–neither long and rambling nor short and lacking substance.	5 to >4.45 ptsExcellentParagraphs and sentences follow writing standards for flow, continuity, and clarity. 4.45 to >3.95 ptsGoodParagraphs and sentences follow writing standards for flow, continuity, and clarity 80% of the time. 3.95 to >3.45 ptsFairParagraphs and sentences follow writing standards for flow, continuity, and clarity 60%–79% of the time. 3.45 to >0 ptsPoorParagraphs and sentences follow writing standards for flow, continuity, and clarity less than 60% of the time.	5 pts
  This criterion is linked to a Learning OutcomeWritten Expression and Formatting – English writing standards: Correct grammar, mechanics, and proper punctuation	5 to >4.45 ptsExcellentUses correct grammar, spelling, and punctuation with no errors 4.45 to >3.95 ptsGoodContains a few (1–2) grammar, spelling, and punctuation errors 3.95 to >3.45 ptsFairContains several (3–4) grammar, spelling, and punctuation errors 3.45 to >0 ptsPoorContains many (≥ 5) grammar, spelling, and punctuation errors that interfere with the reader’s understanding	5 pts
  This criterion is linked to a Learning OutcomeWritten Expression and Formatting – The paper follows correct APA format for title page, headings, font, spacing, margins, indentations, page numbers, running head, parenthetical/in-text citations, and reference list.	5 to >4.45 ptsExcellentUses correct APA format with no errors 4.45 to >3.95 ptsGoodContains a few (1–2) APA format errors 3.95 to >3.45 ptsFairContains several (3–4) APA format errors 3.45 to >0 ptsPoorContains many (≥ 5) APA format errors	5 pts
  Total Points: 100