Off-Label Drug Use in Pediatrics assignment

Nursing
Title: WEEK 11 Assignment: Off-Label Drug Use in Pediatrics
Number of sources: 3
Paper instructions:
WEEK 11. Assignment: Off-Label Drug Use in Pediatrics (see media case at the bottom of the instructions)
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.
Reminder: The College of Nursing requires that all papers submitted include a title page, introduction, summary, and references. The Sample Paper provided at the Walden Writing Center offers an example of those required elements (available at http://writingcenter.waldenu.edu/57.htm). All papers submitted must use this formatting.

THE MEDIA CASE TO WRITE ABOUT

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

Rubric
Explain the circumstances under which children should be prescribed drugs for off-label use. Be specific and provide examples.–

Excellent 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.
Good 32 (32%) – 35 (35%)
The 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.
Fair 28 (28%) – 31 (31%)
The 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.
Poor 0 (0%) – 27 (27%)
The response inaccurately and vaguely explains
—-

Off-Label Drug Use in Pediatrics
The treatment of children and adolescents with mood disorder is often a critical aspect especially when it comes to medication. Such a situation is created by the probability of an off-label use where the pediatric dosage guidelines are not available thereby prompting the patient to engage in the unapproved use of approved drugs (Wimmer, Neubert & Rascher, 2015). For the African American 8-year old patient exhibiting signs of depression, critical therapeutic decisions have to be made concerning the administration of a prescription for the off-label drugs that would facilitate the effective management of their significant mood disorder.
There are distinct circumstances under which children and teenagers should be prescribed off-label drugs. For some children such as the 8-year old patient, their situation is considered to be significant in such a way that offering a prescription cannot be overlooked. In such a case, the healthcare provider ought to integrate consensual statements and comply with the policies and guidelines defined by the American Academy of Pediatrics (AAP). Since there might not be any data available on the administration of off-label drugs, the provider is obliged to establish the pediatric evidence-base depending on the respective situation (Czarniak et al., 2015). For instance, the patient from the case study portrays mood changes, lack of appetite, and poor sleeping patterns which mean that regulated amounts of serotorin would help to reduce the anxiety by relaying signals between the nerve cells in the brain.
To make off-label dosage and use of drugs safer for children, the doctors ought to produce detailed information to the parents or guardians to engage them closely. This is to ensure that the imminent medical and legal risks are fairly managed. The providers acquire substantial historical data of the patient and develop competent decision-making while prescribing (Poznanski & Morkos, 1996). Some of the off-label drugs that require extra attention for pediatrics are the stimulants and antidepressant medications that aim to improve the pediatrics’ ability to learn and focus by reducing impulsivity.
Overall, the administration of off-label drug use as well as their dosage is a relatively critical practice considering the implications that it could lead to in the event that the drugs are not used appropriately. As such, critical therapeutic decisions have to be made concerning the administration of a prescription for the off-label drugs.

References
Czarniak, P., Bint, L., Favié, L., Parsons, R., Hughes, J., & Sunderland, B. (2015). Clinical setting influences off-label and unlicensed prescribing in a paediatric teaching hospital. PloS one, 10(3).
Poznanski, E. O., & Mokros, H. B. (1996). Children’s depression rating scale, revised (CDRS-R). Los Angeles: Western Psychological Services.
Wimmer, S., Neubert, A., & Rascher, W. (2015). The safety of drug therapy in children. Deutsches Ärzteblatt International, 112(46), 781.

Sample Answer: