NURS_6521_Week11_Assignment Off-Label Drug Use in Pediatrics
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Therapy for Pediatric Clients with Mood Disorders
An African American Child Suffering From Depression
BACKGROUND INFORMATION
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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- Mother reports that teacher said child is withdrawn from peers in class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 Paxil 10 mg orally daily
RESULTS OF DECISION POINT ONE
- Client returns to 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 Point Two
Select what you should do next:
Decrease dose for 7 days then return to previous 10 mg day dose
Increase dose to 20 mg orally daily
Change to Prozac 10 mg orally daily
Decision Point Two
Change to Prozac 10 mg orally daily
RESULTS OF DECISION POINT TWO
- Client returns to clinic in four weeks
- There is a 25% reduction in symptoms, client’s side effects of nausea, vomiting, and diarrhea have resolved. Client reports that he is feeling a “little bit better”
Decision Point Three
Select what you should do next:
Increase dose to 20 mg orally daily
Augment with an atypical antipsychotic
Decision Point Three
Guidance to Student
You have two equally compelling choices at this point. The client has only been taking the current drug at its current dose for 4 weeks. It would be appropriate to continue at current dose. Additionally, you could also increase the dose to 20 mg orally daily. A discussion of risk/benefits should be had with the childs guardian regarding this and collaborative decision making should occur. There is no indication at this point that augmentation agents are required as the child is showing a partial response to therapy.
Assignment: Off-Label Drug Use 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.
Photo Credit: Getty Images
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.
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.
By Day 5 of Week 11
Write a 1-page 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.
Rubric Detail
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Name: NURS_6521_Week11_Assignment_Rubric
| Excellent | |
| Explain the circumstances under which children should be prescribed drugs for off-label use. Be specific and provide examples. | 36 (36%) – 40 (40%)
The 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. |
| Explain 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. | 41 (41%) – 45 (45%)
The 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. |
| Written 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 (5%) – 5 (5%)
Paragraphs and sentences follow writing standards for flow, continuity, and clarity. |
| Written Expression and Formatting – English writing standards: Correct grammar, mechanics, and proper punctuation |
5 (5%) – 5 (5%)
Uses correct grammar, spelling, and punctuation with no errors |
| Written 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 (5%) – 5 (5%)
Uses correct APA format with no errors |
Name: NURS_6521_Week11_Assignment_Rubric
Off-Label Drug Use in Pediatrics Sample Approach
NURS 6521 Week 11: Off-label Drug Use in Pediatrics
(A). Circumstances under which children should be prescribed drugs for off-label use
The US Food and Drug Administration (FDA) describes off-label drug prescription as the unapproved use of an approved drug for diseases or medical conditions. In pediatrics, off-label drugs have unauthorized indications, an unapproved age group, and unidentified dosage, or route of administration (Belayneh et al., 2022). Although prescribing off-label drugs may expose children to multiple adverse effects due to limited information regarding the drugs’ appropriate dosage and the preferred age groups, various circumstances favor the prescription of off-label drugs. According to Belayneh et al. (2022), factors that justify the proliferation of off-label drugs in pediatrics include a lack of appropriate pediatric preparations, complicated or limited scientific and ethical requirements in pediatric studies, high formulation costs, and fragmented markets. Other contextual factors that encourage clinicians to prescribe off-label medications include the failure of standard treatment options, a lack of clinical trials, and the presence of rare medical conditions in children.
(B). Strategies to make off-label use and dosage of drugs safer for children from infancy to adolescence. Descriptions and names of off-label drugs that require extra care and attention when used in pediatrics.
Pediatric patients are susceptible to adverse reactions of high-level drugs due to organ system immaturity and ongoing growth and development (Rosenthal & Burchum, 2021). As a result, it is essential to implement evidence-based strategies to enhance the safety of off-label drugs. According to Mei et al. (2019), the recommended approaches for improving the safety of off-label drugs in pediatrics include requesting access to these medications based on supportive scholarly support, frequent assessments by expert groups, approval by an ethics committee, monitoring the drugs’ adverse reactions, obtaining consent from parents, and educating caregivers about appropriate usage of off-label drugs. Equally, establishing a database for off-label drugs can provide a platform for regular updates and information exchange regarding the utilization of these medications.
Off-label use of fentanyl in the field of anesthesia obtains justifications from its solubility and potency. According to Ziesenitz et al. (2018), fentanyl’s mechanism of action entails interactions with the opioid receptor, leading to the analgesic effect during anesthetic periods, immediate postoperative period, premedication, induction, and maintenance. However, this drug is not approved for use outside the perioperative period of pain or sedation. Consequently, its off-label use in children outside the operating room can predispose them to various adverse effects. Oshikoya et al. (2019) argue that off-label use of fentanyl can lead to respiratory depression when used in pediatric ICUs. Clinicians should monitor the pediatric patients’ progress and provide information about the safety of off-label fentanyl use in children
References
Belayneh, A., Abatneh, E., Abebe, D., Getachew, M., Kebede, B., & Dessie, B. (2022). Off-label medication use in pediatrics and associated factors at public hospitals in east Gojjam zone, Ethiopia. SAGE Open Medicine, 10, 1–9. https://doi.org/10.1177/20503121221096534
Mei, M., Xu, H., Wang, L., Huang, G., Gui, Y., & Zhang, X. (2019). Current practice and awareness of pediatric off-label drug use in Shanghai, China -a questionnaire-based study. BMC Pediatrics, 19(1). https://doi.org/10.1186/s12887-019-1664-7
Oshikoya, K. A., Wharton, G. T., Avant, D., Van Driest, S. L., Fenn, N. E., Lardieri, A., Doe, E., Sood, B. G., Taketomo, C., Lieu, P., Yen, L., & McMahon, A. W. (2018). Serious adverse events associated with off-label use of azithromycin or fentanyl in children in intensive care units: A retrospective chart review. Pediatric Drugs, 21(1), 47–58. https://doi.org/10.1007/s40272-018-0318-9
Rosenthal, L., & Burchum, J. (2021). Lehne’s pharmacotherapeutics for advanced practice nurses and physician assistants (2nd ed.). Saunders.
Ziesenitz, V. C., Vaughns, J. D., Koch, G., Mikus, G., & van den Anker, J. N. (2018). Pharmacokinetics of fentanyl and its derivatives in children: A comprehensive review. Clinical Pharmacokinetics, 57(2), 125–149. https://doi.org/10.1007/s40262-017-0569-6