WEEK 11, NURS 6521N, WALDEN, ASSIGNMENT, OFF-Label drug use in Pediatrics

Week 11: Pediatrics
Children, like adults, deal with variety of health issues, but they also have issues that are more prevalent within their population. One issue that significantly impacts children is the prescription of drugs for off-label use. As an advanced practice nurse, how do you determine the appropriate use of off-label drugs in pediatrics? Are there certain drugs that should be avoided with pediatric patients?
This week, you examine the practice of prescribing off-label drugs to children. You also explore strategies for making off-label drug use safer for children from infancy to adolescence, as it is essential that you are prepared to make drug-related decisions for pediatric patients in clinical settings.
Learning Objectives
Students will:
• Evaluate the practice of prescribing off-label drugs to children
• Analyze strategies to make the off-label use of drugs safer for children
• Identify key terms, concepts, and principles related to prescribing drugs to treat patient disorders
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Learning Resources

Required Readings (click to expand/reduce)

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
Note: You will access this article from the Walden Library databases.

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.

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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.
Reminder: The School 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.
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

Increase dose to 37.5 mg orally daily

RESULTS OF DECISION POINT TWO
• Client returns to clinic in four weeks
• Depressive symptoms decrease by 20%. Client reports feeling a little bit better
Decision Point Three

Maintain current dose

Guidance to Student
At this point, sufficient symptom reduction has not been realized. Should either increase dose or consider different SSRI. At 8 weeks post-initiation of therapy, there should have been a significant (as defined as 50%) decrease in symptoms. This would be considered an adequate trial of antidepressant and change in dose or to a different agent would be appropriate.
Therapy for Pediatric Clients with Mood Disorders
An African American Child Suffering From Depression

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

Decrease dose for 7 days then return to previous 10 mg day dose

RESULTS OF DECISION POINT TWO
• Client returns to clinic in four weeks
• Nausea, vomiting, diarrhea subsides with dose reduction, but returns with reinitiation of 10 mg dose
Decision Point Three

Attempt to decrease dose for another 7 days then return to 10 mg dose

Guidance to Student
Temporarily decreasing the drug for 7 days and then increasing is an acceptable option- however, if the side effects return with the reinitiation of the dose, you will need to select a different agent as these side effects are unfavorable to the client and may result in refusal to take treatment. Also, continuing to drop medication dose to subtherapeutic level will do minimal to treat depressive symptoms. Changing to a different SSRI would be the ideal choice as not all SSRIs have the same side effect profile in all clients. It would not be appropriate to increase the dose at this time as it would most likely result in increased intensity of side effects.

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.

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

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

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

Increase dose to 20 mg orally daily

RESULTS OF DECISION POINT TWO
• Client returns to clinic in four weeks
• Nausea, vomiting, and diarrhea has increased and client is refusing to take medication
Decision Point Three

Discontinue Paxil and begin Prozac 10 mg orally daily

Guidance to Student
Temporarily decreasing the drug for 7 days and then increasing is an acceptable option- however, if the side effects return with the reinitiation of the dose, you will need to select a different agent as these side effects are unfavorable to the client and may result in continued refusal to take treatment. Changing to a different SSRI may be appropriate if the trial decrease of dose is unsuccessful and if the nausea, vomiting, and diarrhea return with reinitiation of 20 mg orally daily. Changing the medication may be appropriate as not all SSRIs have the same side effect profile in all clients.
Therapy for Pediatric Clients with Mood Disorders
An African American Child Suffering From Depression

Decision Point One

Begin Wellbutrin 75 mg orally BID
RESULTS OF DECISION POINT ONE
• Client returns to clinic in four weeks
• Child is unable to fall asleep at night
Decision Point Two

Change from immediate release to extended release 150 mg orally daily in the morning

RESULTS OF DECISION POINT TWO
• Client returns to clinic in four weeks
• Child’s sleep patterns return to baseline. No change in depressive symptoms
Decision Point Three

Change to SSRI

Guidance to Student
You can continue drug therapy for another 4 weeks, however, it is discouraging that there have been no changes in depressive symptomatology. Increasing the dose to 300 mg orally daily may be appropriate if the child is tolerating the medication well. Changing to an SSRI may also be appropriate, but it may be more prudent to give the Wellbutrin at an appropriate dose for an adequate duration of therapy before switching therapeutic classes.

REFERENCE GIVEN IN THE SYUDENT PORTAL
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

-REFERENCE GIVEN IN THE STUDENT PORTAL
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• J Pediatr Pharmacol Ther
• v.20(4); Jul-Aug 2015
• PMC4557722

J Pediatr Pharmacol Ther. 2015 Jul-Aug; 20(4): 316–328.
doi: 10.5863/1551-6776-20.4.316
PMCID: PMC4557722
PMID: 26380572
Unlicensed and Off-Label Drug Use in Children Before and After Pediatric Governmental Initiatives
Jennifer Corny, PharmD, Candidate,1 Denis Lebel, BPharm, MSc,1 Benoit Bailey, MD, MSc,2 and Jean-François Bussières, BPharm, MSc, MBA 1,3
Author information Copyright and License information Disclaimer
This article has been cited by other articles in PMC.
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Abstract
OBJECTIVES: Governmental agencies (US Food and Drug Administration and European Medicines Agency) implemented initiatives to improve pediatric clinical research, starting in 1997 and 2007, respectively. The aim of this review was to quantify the unlicensed and off-label drug uses in children before and after these implementations.
METHODS: Literature review of unlicensed and off-label drug uses was performed on PubMed and Google-Scholar from 1985 to 2014. Relevant titles/abstracts were reviewed, and articles were included if evaluating unlicensed/off-label drug uses, with a clear description of health care setting and studied population. Included articles were divided into 3 groups: studies conducted in United States (before/after 2007), in Europe (before/after 2007), and in other countries.
RESULTS: Of the 48 articles reviewed, 27 were included. Before implementation of pediatric initiatives, global unlicensed drug use rate in Europe was found to be 0.2% to 36% for inpatients and 0.3% to 16.6% for outpatients. After implementation, it marginally decreased to 11.4% and 1.26% to 6.7%, respectively. Concerning off-label drug use rates, it was found to be 18% to 66% for inpatients and 10.5% to 37.5% for outpatients before the implementation. After implementation, it decreased marginally to 33.2% to 46.5% and to 3.3% to 13.5%, respectively. In other countries, unlicensed and off-label drug use rates were found to be, respectively, 8% to 27.3% and 11% to 47%.
CONCLUSIONS: Governmental initiatives to improve clinical research conducted in children seem to have had a marginal effect to decrease the unlicensed and off-label drug uses prevalence in Europe.
INDEX TERMS: off-label use, pediatrics, review
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INTRODUCTION
Before a drug can be approved for sale in a given market, governmental authorities in each country have to assess its safety, efficacy, and quality. At the end of this process, pharmaceutical companies are granted market authorization, and the drug gets a license for marketing in the country (e.g., Notice of Compliance in Canada). The drug also has a label (i.e. drug monograph), specifying the details for drug use (e.g., target population, dose, indication, specific use).
Virtually all drugs that get an approval for use in adults should also get an approval for use in children; this is often not the case considering the paucity of clinical research for that population. Therefore, drug monographs are frequently silent about the use of the drug in children. However, in most legislation, clinicians can prescribe to children a drug approved for adult (i.e., an off-label use). In some case, clinicians must also import from another country a drug that has not obtained a license for marketing (i.e., an unlicensed use). Both situations expose clinicians and patients to delays, costs, and risks. In response to these challenges, governmental authorities have established various strategies and regulations to oversee and promote clinical research in children and hopefully to decrease both unlicensed and off-label drug uses.
In 1997, the US Food and Drug Administration (FDA) adopted the FDA Modernization Act (FDAMA),1 followed in 2002 by the Best Pharmaceuticals for Children Act (BPCA),2 which provided an incentive for drug companies to conduct FDA-requested pediatric studies. In 2003, the FDA also created the Pediatric Research Equity Act (PREA), which requires drug companies to study their products in children under certain circumstances.3 In Europe, the European Medicines Agency (EMA) created the European (EU) Pediatric Regulation, in 2007.4 Its objective was to improve the health of children in Europe by facilitating the development and availability of medicines for that population. In other countries, such as in Canada, the Pediatric Expert Advisory Committee was created in 2009 to provide advice to Health-Canada in the development, licensing, and post-approval monitoring of drugs.5
Our hypothesis was that even though these initiatives were not implemented to decrease unlicensed or off-label drug use rates, they probably would have a favorable consequence on those uses. Ten years after the first regulations, we could expect that the prevalence of unlicensed and off-label prescriptions in children would have decreased. Thus, we reviewed the literature to explore the effect of the regulatory changes.
The primary objective of this literature review was to determine the effect of governmental initiatives to improve clinical research in children on unlicensed and off-label drug uses in inpatient and outpatient settings in the world. The secondary objective was to determine the unlicensed and off-label drug use rates in countries where no governmental initiatives to improve clinical research in children have been implemented.
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

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