Week 11 Assignment: Off-Label Drug Use in Pediatrics Walden University

Week 11 Assignment: Off-Label Drug Use in Pediatrics Walden University

Week 11 Assignment: Off-Label Drug Use in Pediatrics Walden University

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•  Mother reports that teacher said child is withdrawn from peers in class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

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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)

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:

Continue current dose

Increase dose to 20 mg orally daily                                                                                          

Augment with an atypical antipsychotic

Decision Point Three

Continue current dose

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.

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Name: NURS_6521_Week11_Assignment_Rubric

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	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

Week 11 Assignment: Off-Label Drug Use in Pediatrics Walden University Sample

Off-label use is the practice of prescribing in-label medications for off-label purposes. Off-label use is a usual practice, especially in pediatric care. 12% of prescriptions in healthcare practice are off-label (Allen et al., 2018). However, off-label use in children from infancy to adolescence is a frequent occurrence globally. The use of off-label drugs in pediatric patients is a topic of debate across the globe. It is common due to limited drugs approved for use in children by the US Food and Drug Administration.

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Circumstances Under with Children should be Prescribed Off-label Drugs

Medical practitioners prescribe off-label drugs to kids due to various reasons. To begin, children should be prescribed off-label medications when there are no FDA-approved medicines for their health conditions (Shakeel et al., 2021). The FDA has not approved any specific medication to be used in treating behavioral issues in kids. Hence, a child with behavioral issues will be prescribed an off-label drug. When there is proof that a drug is useful in treating a specific illness in children, it may also be administered in a manner that is not approved by the Food and Drug Administration (FDA). If there are no drugs that have received FDA approval, then medical practitioners have little choice except to give them off-label since they have no other option. For instance, the FDA has authorized Zoloft for obsessive-compulsive disorder in children and adolescents aged six and under (Kotapati et al., 2019). In spite of this, medical professionals have been giving Zoloft prescriptions to youngsters aged six and older. When it comes to treating asthma in youngsters above the age of 2, albuterol is only FDA-cleared for usage. On the other hand, it is often used in children under the age of two off-label.

Strategies to Make Off-Label Drugs Safer for Children

When it comes to the off-label use of medications, medical practitioners have a responsibility to their clients to guarantee that they have implemented all of the necessary precautions. Off-label medication safety may be improved in many ways. Prior to administering off-label medications, healthcare providers should use clinically appropriate therapies and evidence-based practice to substantiate their decisions (Yackey et al., 2019). In addition to relying on their own knowledge and expertise, healthcare providers must also consider the perspectives of other professionals when making decisions about the use of off-label pharmaceuticals. Furthermore, by attentively watching clients for any negative side effects, healthcare providers may guarantee the safety of off-label medications. In the event that the client claims to experience adverse effects from taking medicine, the treatment should be promptly discontinued. Finally, clinicians need to include the patients’ families in the therapeutic process.

If an off-label medication is shown to be beneficial, a practitioner is legally entitled to prescribe and dispense it to a client without first obtaining the client’s authorization to do so on the basis of informed consent. Parents are a valuable resource in the process of patient monitoring. Due to the potential for undesirable outcomes in young patients, antidepressants like Zoloft and Lexapro are two examples of the kinds of drugs for which special precautions must be taken while prescribing them (Hengartner, 2020). Twitching and trouble urinating are two side effects that have been associated with the usage of the drug Lexapro.

References

Allen, H. C., Garbe, M. C., Lees, J., Aziz, N., Chaaban, H., Miller, J. L., … & DeLeon, S. (2018). Off-label medication use in children, more common than we think: a systematic review of the literature. The Journal of the Oklahoma State Medical Association, 111(8), 776. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6677268/

Hengartner, M. P. (2020). Antidepressant Prescriptions in Children and Adolescents. Frontiers in Psychiatry, 11, 600283. https://www.frontiersin.org/articles/10.3389/fpsyt.2020.600283/full

Kotapati, V. P., Khan, A. M., Dar, S., Begum, G., Bachu, R., Adnan, M., Zubair, A., & Ahmed, R. A. (2019). The effectiveness of selective serotonin reuptake inhibitors for treatment of obsessive-compulsive disorder in adolescents and children: A systematic review and meta-analysis. Frontiers in Psychiatry, 10. https://doi.org/10.3389/fpsyt.2019.00523

Shakeel, S., Nesar, S., Rehman, H., Jamil, K., Mallick, I. A., Mustafa, M. S., Anwar, M., & Jamshed, S. (2021). Patterns and predictors of off-label drug prescribing in psychiatric practice: A qualitative study. Pharmacy, 9(4), 203. https://doi.org/10.3390/pharmacy9040203

Yackey, K., Stukus, K., Cohen, D., Kline, D., Zhao, S., & Stanley, R. (2019). Off-label medication prescribing patterns in pediatrics: An update. Hospital Pediatrics, 9(3), 186-193. https://doi.org/10.1542/hpeds.2018-0168