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.  

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( option drugs below)

· 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.

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.

Therapy for Pediatric Clients with Mood Disorder

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·  Mother reports that teacher said child is withdrawn from peers in class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

Treatment options

1)Zoloft 25 mg orally daily, 2) Paxil 25 mg orally daily, 3) Wellbutrin 75 mg orally BID 

Resources for reference ( 3 + references)

Rosenthal, L. D., & Burchum, J. R. (2018). Lehne’s pharmacotherapeutics for advanced practice providers. St. Louis, MO: Elsevier.

· Chapter 8, “Drug Therapy in Pediatric Patients” (pp. 65—67)

Corny, J., Lebel, D., Bailey, B., & Bussieres, J. (2015). Unlicensed and off-label drug use in children before and after pediatric governmental initiatives. The Journal of Pediatric Pharmacology and Therapeutics, 20(4), 316–328. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4557722/

This article highlights pediatric governmental initiatives to prevent unlicensed and off-label drug use in children. Review these initiatives and guidelines and how they might impact your practice as an advanced practice nurse.

Panther, S. G., Knotts, A. M., Odom-Maryon, T., Daratha, K., Woo, T., & Klein, T. A. (2017). Off-label prescribing trends for ADHD medications in very young children. The Journal of Pediatric Pharmacology and Therapeutics, 22(6), 423–429. doi:10.5863/1551-6776-22.6.423

This study examines the frequency of off-label prescribing to children and explores factors that impact off-label prescribing. This study also examines off-label prescribing to children with ADHD.

Required Media (click to expand/reduce)

Laureate Education (Producer). (2019i). Therapy for pediatric clients with mood disorders [Interactive media file]. Baltimore, MD: Author.

Course: Nursing Informatics

Assignment details:

 

Scenario: You are speaking in a meeting with the hospital compliance officer and the hospital representative for Health Insurance Portability and Accountability Act of 1996 (HIPAA) team, and have been asked “How will we maintain patient privacy with our documents on the Internet?”

Use the university library, journals, and your experience to create a strategic plan for a 200-bed acute care facility that considers possible data privacy breaches and proposes effective methods to avoid them. Additionally, explain what is required by the Joint Commission, the Health Information on Technology for Economic and Clinical Health (HITECH) Act, and the HIPAA regulations that must be followed for the protection of individually identifiable health information.

Cite at least 4 peer-reviewed references published within the past 5 years.

• Using the format outlined on the PICO reference page in the Nursing Reference Center design your own question. (This may be related to something you are familiar with, or something you imagine to be an issue in nursing. It is BEST if you keep it simple!)
• Next research reliable data bases or websites and find three articles that are related to your PICO (these MUST BE referenced on your reference page).
• Analyze the articles – write one paragraph about the similarities and/or differences in the articles related to your PICO.

Your Essay should be outlined by using steps 1-3 of the EBP process. 

Submit your completed assignment by following the directions linked below. Please check the Course Calendar for specific due dates.

Save your assignment as a Microsoft Word document. (Mac users, please remember to append the “.docx” extension to the filename.) The name of the file should be your first initial and last name, followed by an underscore and the name of the assignment, and an underscore and the date. An example is shown below:

 

Submit an evidence-based practice paper about cultural competency in mental health nursing. An evidence-based practice paper allows you to explore best practice and help improve client outcomes on a psychiatric unit. Your paper should describe how you, as a nurse, will include – or have included – cultural awareness in a client diagnosed with a mental illness. The person you describe could be someone in your clinical setting, someone you have worked with in the past, or a theoretical client.

Remember that culture can also include gender equality, sexual orientation, and other cultures besides race and religion – including cultures unique to one particular family. Your paper should be at least 3 pages (double-spaced, not including the title or reference pages) in APA Format and include:

• Assessment: Discuss what you would assess in regard to a client’s culture. For example, are there specific dietary requirements? Are schedule changes necessary to avoid conflicts with religious practices? Who is the spokesperson for the family? What would you assess?
• Diagnosis: List any mental health nursing diagnoses this person has or may be at risk for. Include at least one cultural diagnosis.
• Planning: What planning needs to be done to ensure the cultural and emotional safety of the client?
• Implementation: What are interventions that would ensure the safety of your client in regard to culture? Include at least two interventions. For example, if your client has religious beliefs that affect the ability to take medications, what interventions would you create to ensure the client’s safety? What can you do to make sure the client’s cultural needs are met?
• Evaluation: How will you evaluate whether your implementation was effective? Make sure the parameters are objective and measurable.
• In your summary, discuss whether any completed interventions were successful. What could be done differently in the future? If the interventions have not yet been carried out, you might discuss some institutional changes that could be made to ensure cultural safety for all clients in that setting.

Your paper should utilize proper APA guidelines and include at least three scholarly sources to support your paper. A scholarly source is a source that has been peer reviewed and has appropriate authors that are credentialed