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.  

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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.

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• Mother reports that teacher said child is withdrawn from peers in class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

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.

Therapy for Pediatric Clients with Mood Disorders
An African American Child Suffering From Depression

Decision Point One

Begin Zoloft 25 mg orally daily

RESULTS OF DECISION POINT ONE

• Client returns to clinic in four weeks
• No change in depressive symptoms at all

Decision Point Two

Select what you should do next:

Increase dose to 50 mg orally daily

RESULTS OF DECISION POINT TWO

• Client returns to clinic in four weeks
• Depressive symptoms decrease by 50%. Cleint tolerating well

Decision Point Three

Select what you should do next:

Maintain current doseGuidance to Student
At this point, sufficient symptom reduction has been achieved. This is considered a “response” to therapy. Can continue with current dose for additional 4 week to see if any further reductions in depressive symptoms are noted. An increase in dose may be warranted since this is not “full” remission- Discuss pros/cons of increasing drug dose with client at this time and empower the client to be part of the decision. There is no indication that the drug therapy should be changed to an SNRI at this point as the client is clearly responding to this therapy.

 

Respond  to your  colleagues by comparing the differential diagnostic features of the  disorder you were assigned to the diagnostic features of the disorder  your colleagues were assigned. 

NOTE: Positive comment
(bellow is attached the sleep disorder assigned to me)

                                                              Main Post

Diagnostic criteria for Sleep/Wake Disorder. (Nightmare Disorder)
    Nightmare disorders occur when the persons experiences nightmares  regular or severe nightmares. The nightmare disorder is categorized  under parasomnia of sleep disorders. It is characterized by abnormal  experiences and events that occur when a person falls asleep, sleeping,  or waking up. These individuals usually have frequent dreams that induce  fear, anxiety and other negative feelings. causes fear and hinders  normal daytime functioning. In the diagnostic criteria for the nightmare  disorder, various factors are considered in order to diagnose the  disorder. Some of these factors include if an individual has repeatedly  distressful dreams that generally consist of their wellbeing and safety  which they try to avoid and they generally occur during the second half  of the major sleep cycle (Dietch, et al., 2020). If a person upon waking  up from the nightmare becomes alert and oriented rather quickly, and if  the nightmare results in great distress and impairment in vital areas  of life such as occupations and social life, they can be used to  diagnose the disorder. Another criterion for the diagnosis is if another  condition does not effectively explain the main complaint of  distressful dreams and if the nightmares are not due to physiological  effects of a particular substance like medication or an abusive drug.  There are no known tests that can diagnose this disorder (Mayo Clinic,  2017). However, a patient suffering from nightmare disorder is properly  examined by a doctor by establishing any medical history and analyzing  symptoms. The diagnosis may include a physical exam that aims at  identifying possible conditions that may influence the nightmares. If  the nightmares are recurrent and indicate anxiety, the patient may be  referred to a mental health professional. The diagnosis can also involve  symptoms discussion. The doctor can inquire about sleeping behaviors  and family history of sleeping disorder. The doctor can also discuss  other possible causes of the sleeping disorder. The doctor can also  recommend for a Polysomnography where an overnight sleep study is  undertaken to determine if the nightmares result from other sleep  disorders. Sensors are attached to the body to record heart rate, brain  waves, the oxygen level in the blood, movements of the eyes and legs,  and breathing rates (Mayo Clinic, 2017).
Evidence-Based Psychotherapy and Psychopharmacologic Treatment for your assigned sleep/wake disorder. (Nightmare Disorder)
    The underlying cause of this disorder helps in determining the type of  treatment intervention. The evidence-based psychotherapy treatment for  the nightmare disorder that has been carried out and found to be  effective include rescripting therapy is used when nightmares are caused  PTSD (Standard of Practice Committee, 2010). The most substantial  evidence that was obtained was in image rehearsal therapy because the  treatment addressed the disorder with a secondary benefit being the  possibility of relieving the distress linked with nightmares.  Rescripting, relaxation, and exposure therapy treatments aim to reduce  anxiety related to nightmares; it uses progressive muscle relaxation,  sleep hygiene, and psycho education techniques. The evidence-based  psychopharmacologic treatment used to treat the nightmare disorder  includes Trazodone, Prazosin, Gabapentin, Fluvoxamine, Clonidine,  Risperidone and Olanzapine.  Much evidence has been obtained about  Prazosin, and it is commonly used to treat Anxiety and High Blood  Pressure (Yucel, et al., 2020). Clonidine is used for the treatment of  Insomnia, High Blood Pressure, and stress while Gabapentin treats  Seizures and Neuropathic pain. With Tricyclic and Trazodone  antidepressants, they are used to treat Depression and Insomnia.
Primary Care Physician for an additional referral (Nightmare Disorder)
    Occasional nightmares may not always be a cause of concern. If a child  experiences nightmare, it is essential to mention this during routine  well-child exams and programs. However, it is important to consult the  doctor if the nightmares occur frequently and persist for a long period.  The doctor can also be consulted if they routinely disrupt sleep  patterns and a patient gradually wakes up into the night. If the  nightmares cause great fear before sleeping and if they impact  individual behavior and daytime functioning, it is crucial to consult a  doctor (Stefani, 2020).The  nightmares are persistent can lead to mental health problems such as  Anxiety and Depression as the dreams continue to bother the individual. A  person may also resist going to bed or sleeping due to fear of having  bad dreams. This, in turn, causes them to have excessive daytime  sleepiness that impacts their productivity and efficiency both at school  and at work. It also affects daily tasks that involve concentration and  commitment. Nightmare disorder has also resulted in adverse impacts  such as suicidal thoughts and attempts if the problem is not identified  and treated early.Additionally, if the patient may be having comorbid  medical conditions, they will have to be referred to the appropriate  specialist.
References
Dietch,  J. R., Taylor, D. J., Pruiksma, K., Wardle-Pinkston, S., Slavish, D.  C., Messman, B., … & Kelly, K. (2020). The Nightmare Disorder  Index: development and initial validation in a sample of nurses. Sleep.
Mayo Clinic (July 6, 2017). Nightmare disorder- Diagnosis and Treatment. Retrieved from: https://www.mayoclinic.org/diseases-conditions/nightmare-disorder/diagnosis-treatment/drc-20353520
Standards  of Practice Committee, Aurora, R. N., Zak, R. S., Auerbach, S. H.,  Casey, K. R., Chowdhuri, S., … & Morgenthaler, T. I. (2010). Best practice guide for the treatment of nightmare disorder in adults. Journal of clinical sleep medicine, 6(4), 389-401.
Yücel, D. E., van Emmerik, A. A., Souama, C., & Lancee, J. (2020). Comparative  efficacy of imagery rehearsal therapy and prazosin in the treatment of  trauma-related nightmares in adults: A meta-analysis of randomized  controlled trials. Sleep medicine reviews, 50, 101248.
Stefani, A., & Högl, B. (2020). Nightmare Disorder and Isolated Sleep Paralysis. Neurotherapeutics, 1-7.