Nursing
\nTitle: \tWEEK 11 Assignment: Off-Label Drug Use in Pediatrics
\nNumber of sources: \t3
\nPaper instructions:
\nWEEK 11. Assignment: Off-Label Drug Use in Pediatrics (see media case at the bottom of the instructions)
\nThe 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.
\nWhen treating children, prescribers often adjust dosages approved for adults to accommodate a child\u2019s weight. However, children are not just \u201csmaller\u201d adults. Adults and children process and respond to drugs differently in their absorption, distribution, metabolism, and excretion.<\/p>\n
Photo Credit: Getty Images
\nChildren 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.
\nTo Prepare
\nReview the interactive media piece in this week\u2019s Resources and reflect on the types of drugs used to treat pediatric patients with mood disorders.
\nReflect on situations in which children should be prescribed drugs for off-label use.
\nThink 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.
\nBy Day 5 of Week 11
\nWrite a 1-page narrative in APA format that addresses the following:
\nExplain the circumstances under which children should be prescribed drugs for off-label use. Be specific and provide examples.
\nDescribe 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.
\nReminder: 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.<\/p>\n
THE MEDIA CASE TO WRITE ABOUT<\/p>\n
BACKGROUND INFORMATION
\nThe client is an 8-year-old African American male who arrives at the ER with his mother. He is exhibiting signs of depression.
\nClient complained of feeling \u201csad\u201d
\nMother reports that teacher said child is withdrawn from peers in class
\nMother notes decreased appetite and occasional periods of irritation
\nClient reached all developmental landmarks at appropriate ages
\nPhysical exam unremarkable
\nLaboratory studies WNL
\nChild referred to psychiatry for Assessment<\/p>\n
MENTAL STATUS EXAM
\nAlert & oriented X 3, speech clear, coherent, goal directed, spontaneous. Self-reported mood is \u201csad\u201d. 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.<\/p>\n
You administer the Children’s Depression Rating Scale, obtaining a score of 30 (indicating significant depression)<\/p>\n
RESOURCES
\n\u00a7 Poznanski, E., & Mokros, H. (1996). Child Depression Rating Scale–Revised. Los Angeles, CA: Western Psychological Services.<\/p>\n
Decision Point One
\nSelect what you should do:<\/p>\n
Begin Zoloft 25 mg orally daily
\nBegin Paxil 10 mg orally daily
\nBegin Wellbutrin 75 mg orally BID<\/p>\n
Rubric
\nExplain the circumstances under which children should be prescribed drugs for off-label use. Be specific and provide examples.–<\/p>\n
Excellent 36 (36%) – 40 (40%)
\nThe response accurately and thoroughly explains in detail the circumstances under which children should be prescribed drugs for off-label use.<\/p>\n
The response includes accurate and specific examples that fully support the explanation provided.
\nGood 32 (32%) – 35 (35%)
\nThe response accurately explains the circumstances under which children should be prescribed drugs for off-label use.<\/p>\n
The response includes accurate examples that support the explanation provided.
\nFair 28 (28%) – 31 (31%)
\nThe response inaccurately or vaguely explains the circumstances under which children should be prescribed drugs for off-label use.<\/p>\n
The response includes inaccurate or vague examples that may or may not support the explanation provided.
\nPoor 0 (0%) – 27 (27%)
\nThe response inaccurately and vaguely explains
\n—-<\/p>\n
Off-Label Drug Use in Pediatrics
\nThe 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.
\nThere 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.
\nTo 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\u2019 ability to learn and focus by reducing impulsivity.
\nOverall, 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.<\/p>\n
References
\nCzarniak, P., Bint, L., Favi\u00e9, 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).
\nPoznanski, E. O., & Mokros, H. B. (1996). Children’s depression rating scale, revised (CDRS-R). Los Angeles: Western Psychological Services.
\nWimmer, S., Neubert, A., & Rascher, W. (2015). The safety of drug therapy in children. Deutsches \u00c4rzteblatt International, 112(46), 781.<\/p>\n
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