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:
Learning Resources
Rosenthal, L. D., & Burchum, J. R. (2018). Lehne’s pharmacotherapeutics for advanced practice providers. St. Louis, MO: Elsevier.
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)
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. Assignment: Off-Label Drug Use in Pediatrics
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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
By Day 5 of Week 11
Write a 1-page narrative in APA format that addresses the following:
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.
Sample Essay
In contrast to adults, there is less evidence on drug dosage, effectiveness, and safety in children. This scarcity of data can be ascribed to various factors, including the pharmaceutical industry’s lack of expertise with age-related developmental pharmacology in pediatric patients, ethical concerns with doing pediatric research, and a lack of financial motivation. As a result, numerous critical therapeutic mishaps with off-label usage of medicines affecting children have occurred throughout the years, with thalidomide and chloramphenicol being famous examples. This paucity of understanding of juvenile drug usage is a continuing source of worry that requires extensive investigation. Many doctors are obliged to administer medicines off-label until more research and applications are conducted. The American Academy of Pediatrics issued a policy statement on the use of off-label medications in children in response to this practice gap, defining off-label use as “use of a drug not included in the package insert (FDA-approved labeling) [and] does not imply improper, illegal contraindicated, or investigational use.” (Food and Drug Administration, 2016)
The Practice of Prescribing Off-Label Drugs to Children
In the past, assessing medicines in the juvenile population has proven difficult. Due to scientific, ethical, clinical, and logistic problems, children offer special considerations in clinical trials, which have historically limited and even prohibited the testing of medicines in this population. As a result, most medicines used in the treatment of children have been used off-label due to a lack of knowledge about proper dose, safety, or efficacy. Furthermore, off-label drug use has been linked to negative consequences. Recent studies, such as those detailed in Hoon et al.’s (2019) article in this issue of Pediatrics, show that off-label prescription trends in children remain prevalent. The focus of this research varies, with some focusing on inpatient populations and others on ambulatory settings. Compared to others, certain drug classes, medical conditions, and patient ages have been shown to have more excellent rates of off-label pharmaceutical use. The conclusions, on the other hand, are consistent. Overall, children are still getting medicines that aren’t on the label and for unapproved illnesses.
Strategies to Make the Off-Label Use of Drugs Safer For Children
Both the AAP (2015) and Bourgeois (2018) agree that when determining whether to administer medication with no pediatric labeling, clinicians should use their best judgment and available evidence. As the authors note out, there are a variety of resources available to physicians looking for information about a medication’s pediatric usage and safety, including consensus assertions from peer-reviewed literature, policies and practice guidelines from the American Academy of Pediatrics, data from the Cochrane Collaboration and UpToDate, as well as the FDA’s MedWatch program. Providers should also depend on their own and colleagues’ knowledge and any expert views and trial data available to them. The absence of formal evidence does not imply that no evidence exists to inform prescription. Finding, collecting, and evaluating that evidence, on the other hand, may be complex and require more work on the provider’s side. Providers can play an essential role in helping to establish the pediatric evidence base for medication, especially for infants and children with uncommon diseases for which there is little to no data. When it comes to medicines for children, there are a few that require special consideration. Oseltamivir, psychostimulants, opioids, and antidepressants are among the most commonly prescribed medication in this group. Antidepressants increase the chance of suicide. This is why all medicines used to treat depression in children come with a black box warning (Food and Drug Administration, 2016).
Key Terms, Concepts, and Principles Related To Prescribing Drugs to Treat Patient Disorders
The possible hazards and advantages to each patient must be considered when prescribing pharmaceutical therapy. Health care practitioners should discuss these potential dangers and benefits with patients, family members, and patients’ caretakers (Mueller et al., 2019). Prescriptions should not be written until a thorough clinical evaluation has been performed and the psychological causes behind symptoms have been investigated. The patient should understand that the treatment is for a set amount of time. This time frame might be influenced by the pharmacological characteristics of the medicines used and the treated disease.
The Circumstances Under Which Children Should Be Prescribed Drugs for Off-Label Use
When a juvenile patient has exhausted all other permitted alternatives, such as uncommon illnesses or cancer, off-label medicines might be administered. Because a chemotherapy medicine licensed for one form of cancer may target many distinct types of cancers, according to Haines et al. (2018), cancer treatment sometimes entails taking specific chemotherapy treatments off-label. Off-label usage of a medication or a drug combination is frequently the gold standard of therapy. Beta-blockers are another example of an off-label prescription that can be helpful. These medicines are FDA-approved for treating high blood pressure, but cardiologists consider them the standard of care for heart failure patients. Certain beta-blockers are now authorized for the treatment of heart failure. Off-label applications are prevalent, and the FDA frequently approves them.
In the pediatric population, especially in newborns and lower age groups, off-label drug usage is prevalent. To ensure appropriate medication safety and effectiveness for children, further age-specific research is required. The best available evidence should guide clinical decision-making until further data is available.
References
American Academy of Pediatrics. (2015). Off-label use of drugs in children. Pediatrics, 133(3). Retrieved from http://pediatrics.aappublications.org/content/pediatrics/133/3/563.full.pdf
Bourgeois, F. (2018). What to consider when considering “off-label” drug prescriptions for children. Boston Children’s Hospital. Retrieved from https://www.childrenshospital.org/centers-and-services/departments-and-divisions/division-of-general-pediatrics/clinician-resources/off-label-drug-prescriptions
Food and Drug Administration. (2016). Drug Research and Children. https://www.fda.gov/drugs/resourcesforyou/consumers/ucm143565.htm
Haines, E. R., Frost, A. C., Kane, H. L., & Rokoske, F. S. (2018). Barriers to accessing palliative care for pediatric patients with cancer: a review of the literature. Cancer, 124(11), 2278-2288.
Hoon, D., Taylor, M. T., Kapadia, P., Gerhard, T., Strom, B. L., & Horton, D. B. (2019). Trends in off-label drug use in ambulatory settings: 2006–2015. Pediatrics, 144(4). https://scholar.google.com/scholar_lookup?author=D+Hoon&author=M+Taylor&author=P+Kapadia&title=Trends+in+off-label+drug+use+in+ambulatory+settings%3A+2006%E2%80%932015&publication_year=2019&journal=Pediatrics&volume=144
Mueller, B. U., Neuspiel, D. R., & Fisher, E. R. S. (2019). Principles of pediatric patient safety: reducing harm due to medical care. Pediatrics, 143(2).
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.
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
Decision Point One
Select what you should do:
Decision Point One
Begin Paxil 10 mg orally daily
RESULTS OF DECISION POINT ONE
Decision Point Two
Increase dose to 20 mg orally daily
RESULTS OF DECISION POINT TWO
Decision Point Three
Discontinue Paxil and begin Prozac 10 mg orally daily
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 STUDENT 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
Sample Essay
Depression
Depression is a mental health disorder characterized by loss of reactivity, psychomotor retardation, and agitation. Over 7.6% of children below 12 years old in the United States of America suffer from depression. Causes of depression in children are poor parent-child interaction, vascular depression, and neuroendocrine abnormalities. Signs and symptoms of depression in children are sad behavior. The child is worried or afraid a lot. The baby is aggressive, won’t do what you ask them to do most of the time, and tantrums. The child feels guilty after a small mistake, and they keep complaining of pain without any physical hurt. There is a sudden change in the child’s interest; loss of energy, sleeping problems, no interest in playing, doesn’t want to be around friends and having problems concentrating. These changes affect the child’s academic performance and relationship with playmates. The American psychiatric association DSM-5 criteria for depression includes depressed mood, loss of interest, slowdown of thought process, fatigue, inappropriate guilt, and loss of concentration. The child has depression due to symptoms like sadness. The child is withdrawn from the peer class, decreased appetite, and has occasional periods of irritation. The mental state examination confirms depression because the child admits to being sad and has a blunted affect. He has thoughts of being dead and would like to be dead. The children’s depression rating scale obtained a score of 30, indicating significant depression. The purpose of this paper is to discuss the decisions made in the treatment of depression.
Decision 1#
Decision Selected
Zoloft 25mg orally daily
Reason For Selecting The Decision
Zoloft or sertraline is a selective serotonin reuptake inhibitor SSRI FDA-approved in treating the major depressive disorder, anxiety, ADHD, and OCD in children. Zoloft is an antidepressant that inhibits the reuptake of serotonin in the central nervous system to regulate mood, personality, and wakefulness (Anvari, et al, 2020). The drug is taken orally once daily from 25mg to a maximum of 200mg daily. Zoloft has side effects such as dizziness, lightheadedness, fatigue, diarrhea, and nausea. It is the most appropriate drug for the patient because FDA recommends it in treating depression and it helps in relieving its symptoms. Compared to other antidepressants, the drug is tolerable in children and has fewer side effects. Zoloft increases suicidal ideation among patients. Therefore, the child should attend psychotherapy sessions for cognitive and behavioral change. Moreover, he should be under close suicidal watch from the parents and other care providers.
Why I Did Not Select The Other Two Options
Paxil is a selective serotonin reuptake inhibitor for treating depression, obsessive-compulsive disorder, anxiety, and post-traumatic stress disorder. Paxil blocks the serotonin reuptake transporter to increase the presynaptic serotonin concentration that contributes to its antidepressant effect. However, I did select Paxil for this patient because its safety in children less than 18 years is yet to be established. Moreover, Paxil has severe adverse effects in children, such as nausea, vomiting, dizziness, and confusion (Lacasse, et al, 2021). Paxil has an increased risk of suicidal ideation and attempts compared to Zoloft. Therefore, it is not a suitable drug for this child.
Wellbutrin is an antidepressant FDA approved for smoking cessation, adult depression, ADHD, and sexual dysfunction. It inhibits the reuptake of dopamine and norepinephrine. It also acts on the nicotinic and serotonin receptors. However, the onset of its effect is two weeks after drug intake (Mast, et al, 2019). I did not select this drug for this patient because there is no clear indication of its safety and effectiveness in children. In addition, the drug takes a longer duration before it proves its effectiveness.
The expected outcome
After administering Zoloft 25mg orally, I was expecting the patient to improve their sleep, mood, concentration, and activity. There would be a significant decrease in the children’s depression scale. I also expected the child would complain of mild headache, dizziness, and nausea.
Ethical consideration
Ethics are the moral values that guide the nursing practice. The PNP should apply ethical principles such as consent, beneficence, and non-maleficence (McDermott-Levy, et al, 2018). Consent act of seeking permission from a patient or the guardian before initiating treatment. The child is less than 18 years old. Therefore, he cannot consent to his treatment. As the PNP, I would inform the guardian of the illness affecting the child and the treatment methods. Then, I would request them to sign the consent form. Beneficence is having the best interest of a patient by doing the right thing. I would apply beneficence by prescribing the best medication that would relieve the symptoms. Non-maleficence is protecting the patient from harm. I would apply this by avoiding medication errors during prescription and dispensing the medicine. In addition, I would recommend a tolerable drug with no side effects.
Decision Two#
Decision Selected
Increase the dose to 50mg orally daily
Reason For Selecting The Decision
The patient reports slight improvement from the previous symptoms. There was a slight increase in the mood, no HAM-D results, and the patient did not experience adverse effects. This is an indication that the drug is effective for this patient. According to Anvari, et al, (2020), Zoloft dosage increment is by 50% to establish its effectiveness in a patient.
Why I Did Not Select The Other Two Options
I did not increase the dose to 37.5mg because the American psychiatric association recommends dosage increments by 25-50mg to establish the effectiveness of the drug. Prozac is an antidepressant that lowers the levels of serotonin uptake sites causing the activating effect. It is used as an off-label drug in treating ADHD and anxiety disorder. However, its effectiveness and efficiency are established two to four weeks after initiating the treatment. Therefore, I did not select this drug because of adverse side effects and the longer duration of action.
The Expected Outcome
During the second visit, I was expecting the child will improve the symptoms by 50%. This includes, improves speech and concentration, ability to interact with other children, and decrease of the HAM-D results. The child did not complain of any side effects in the previous visit. Therefore, I did not expect any side effects.
Ethical Consideration
As the PNP, I will apply the principle of efficiency and proportionality when treating this patient. Proportionality is the quality of being in proper balance about treatment. This expounds on the principle of justice and fairness by maintaining the quality of care through all the stages of treatment (McDermott-Levy, et al, 2018). Efficiency is an action that brings out the best results, especially in patients. As the PNP, my main goal is to produce the desired results and ensure there is patient satisfaction.
Decision Three#
Decision Selected
Maintain the current dose
Reason For Selecting This Decision
Zoloft 50mg orally improved the patient’s symptoms by 50%. I would continue with the same dose to achieve the maximum effect of the drug.
Why I Did Not Select The Other Two Options
I did not increase Zoloft to 75mg because it is not appropriate for children. The American psychiatric association recommends 50mg as the maximum dosage. In addition, increasing the dosage to 75mg may precipitate adverse effects. I did not change to SNRI because the drug was already effective in the patient’s symptoms. There is no indication for switching the patient to a new drug at this level. In addition, SNRIs have severe side effects compared to SSRIs.
The Expected Outcome
After weeks of drug continuation, my expectation is for the child to fully recover and restore both behavioral and cognitive functions. The child would not experience any side effects because it has been tolerable in the previous stages.
Ethical Considerations
During the third visit, I will apply the principle of respect for autonomy. Autonomy is the principle that allows the patient to make informed medical decisions (McDermott-Levy, et al, 2018). As the PNP, I would empower the guardian about the disease and treatment process to facilitate informed decisions.
Conclusion
Conclusively, depression is a disorder whose main symptoms are loss of interest, suicidal ideation, sleep disturbance, agitation, and loss of cognitive functions. Treatment modalities in depression can be psychotherapy and pharmacotherapy. Selective serotonin reuptake inhibitors are the most appropriate antidepressants for children. They are tolerable and have less severe side effects. Ethical principles are the moral values that guide treatment and nursing practice. These principles are consent, beneficence, non-maleficence, respect for autonomy, efficiency, and proportionality.
References
Anvari, A. A., Carroll, M. P., & Klein, D. A. (2020). Primary Care Clinicians Can Effectively Treat Depression in Children and Adolescents. American Family Physician, 102(4), 198-199.
Lacasse, J. R., Dunleavy, D. J., & Hughes, S. (2021). Psychiatric Prescribing in Child Welfare: Barriers to Evidence-Based Practice and an Agenda for Reform. Child and Adolescent Social Work Journal, 1-15.
Mast, R., Harper, B., Pollock, K., & Gentile, J. P. (2019). Pharmacologic Treatment of Attention Deficit Disorder in Children and Adolescents: Executive Function Agents, Stimulants, and Sympathomimetic Amines. J Clin Med Ther, 4(1).
McDermott-Levy, R., Leffers, J., & Mayaka, J. (2018). Ethical principles and guidelines of global health nursing practice. Nursing Outlook, 66(5), 473-481.
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