OFF-LABEL DRUG USE IN PEDIATRICS NURS 6521

A Sample Answer For the Assignment: OFF-LABEL DRUG USE IN PEDIATRICS NURS 6521

Situations When Off Label Medications May be Used in Pediatrics

There are specific situations when medications in the regard of off-label medications can be given to children. For instance, whenever a drug which is meant to manage a particular condition has been used without demonstrable success, a physician can choose a different alternative to save the day (“Off-Label use of Medicines in Children,” n.d.). A physician may be compelled to prescribe a drug to a pediatric when a particular formulation is available in a different country in another possible scenario. Yet there are acute shortages in their areas of jurisdiction.

On the other hand, the physician can make an importation request for a drug used in another country for adults but for children in their country (Allen et al., 2018). Examples of the off-label medications used in children include amoxicillin, used for different conditions, including otitis media. There are specific medications which are high risk and should be used with caution in paediatrics, including dopamine, hydromorphone, oxycodone and lorazepam (Czaja et al., 2015). The medication could cause pronounced psychological effects or even unforeseen death.

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Strategies for Off-label Medications for Pediatrics

Whenever off-label medications are used in children, there ought to be strategies to ensure they attain the best possible outcomes with minimal adverse effects. More clinical trials should be considered but within the safety and ethical parameters in children to establish the efficacy of medications (Tefera et al., 2017). The healthcare providers, the nurses, physicians and pharmacists should have efficient reporting methods and address the occurrence of adverse effects in children, which would then enhance the use of the medications.

References

Allen, H. C., Garbe, M. C., Lees, J., Aziz, N., Chaaban, H., Miller, J. L., … DeLeon, S. (2018). Off-Label Medication use in Children, More Common than We Think: A Systematic Review of the Literature. The Journal of the Oklahoma State Medical Association, 111(8), 776–783. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/31379392

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Czaja, A. S., Reiter, P. D., Schultz, M. L., & Valuck, R. J. (2015). Patterns of off-label prescribing in the pediatric intensive care unit and prioritizing future research. Journal of Pediatric Pharmacology and Therapeutics, 20(3), 186–196. https://doi.org/10.5863/1551-6776-20.3.186

OFF-LABEL USE OF MEDICINES IN CHILDREN | INTERNATIONAL JOURNAL OF PHARMACEUTICAL SCIENCES AND RESEARCH. (n.d.). Retrieved February 2, 2021, from https://ijpsr.com/bft-article/off-label-use-of-medicines-in-children/?view=fulltext

Tefera, Y. G., Gebresillassie, B. M., Mekuria, A. B., Abebe, T. B., Erku, D. A., Seid, N., & Beshir, H. B. (2017). Off-label drug use in hospitalized children: A prospective observational study at gondar university referral hospital, northwestern Ethiopia. Pharmacology Research and Perspectives, 5(2), 304. https://doi.org/10.1002/prp2.304

The term “off-label usage” refers to the use of a medicine for purposes, administration methods, indications, patient ages, or intended objectives that are not officially approved or authorized (Hengartner, 2020). For example, the majority of antidepressants have received approval only for adult populations, necessitating their off-label use in pediatric patients. The purpose of this paper is to examine the many categories of non-FDA-authorized medications used in the treatment of mood disorders among pediatric populations.

Reasons for Children’s Off-Label Drug Use

According to Solmi et al. (2020), there are certain circumstances when the prescription of medications for off-label usage in pediatric patients is deemed permissible. An illustrative instance occurs when a pediatric patient presents with a rare medical condition without any therapy alternatives authorized by the Food and Drug Administration (Egberts et al., 2022). Another illustration arises when a youngster presents with a prevalent ailment, although the treatment sanctioned by the Food and Treatment Administration (FDA) proves to be ineffective or poorly tolerated (Hoon et al., 2019).

Improve Safety

Regardless of the justification, children using off-label drugs run the risk of experiencing major unfavorable side effects. Additional clinical research is necessary to improve the safety of pediatric patients using off-label medications (Hengartner, 2020). The benefits and risks of a medication must be considered before giving it to a child. Prescribers are recommended to adopt evidence-based dosage approaches, like the Clarks rule, to guarantee that the children get the right quantity, route of administration, and frequency of the drug to prevent adverse effects (Egberts et al., 2022).

The FDA warns against taking medications with serious side effects, like SSRIs, that can cause suicidal ideation in pediatric patients (Solmi et al., 2020). Due to the increased likelihood of suicidal ideation and self-injurious behaviors in this age range, children should be careful when taking medications like fluoxetine, and paroxetine (Hoon et al., 2019).

Conclusion

Practitioners frequently prescribe off-label medications for children due to insufficient data on drug dosage, efficacy, and safety in this population. The majority of medications administered to children are not specifically formulated for pediatric use, and a significant proportion of these prescriptions lack sufficient testing in pediatric populations. Due to the limited availability of pediatric evidence, healthcare professionals may administer medications that pose potential risks to children. Therefore, it is imperative to conduct ongoing research specifically focused on this age group.

References

Egberts, K. M., Gerlach, M., Correll, C. U., Plener, P. L., Malzahn, U., Heuschmann, P., Unterecker, S., Scherf-Clavel, M., Rock, H., Antony, G., Briegel, W., Fleischhaker, C., Häge, A., Hellenschmidt, T., Imgart, H., Kaess, M., Karwautz, A., Kölch, M., Reitzle, K., & Renner, T. (2022). Serious Adverse Drug Reactions in Children and Adolescents Treated On- and Off-Label with Antidepressants and Antipsychotics in Clinical Practice. Pharmacopsychiatry. https://doi.org/10.1055/a-1716-1856

Hengartner, M. P. (2020). Editorial: Antidepressant Prescriptions in Children and Adolescents. Frontiers in Psychiatry, 11. https://doi.org/10.3389/fpsyt.2020.600283

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://doi.org/10.1542/peds.2019-0896

Solmi, M., Fornaro, M., Ostinelli, E. G., Zangani, C., Croatto, G., Monaco, F., Krinitski, D., Fusar‐Poli, P., & Correll, C. U. (2020). Safety of 80 antidepressants, antipsychotics, anti‐attention‐deficit/hyperactivity medications, and mood stabilizers in children and adolescents with psychiatric disorders: a large scale systematic meta‐review of 78 adverse effects. World Psychiatry, 19(2), 214–232. https://doi.org/10.1002/wps.20765

Situations When Off Label Medications May be Used in Pediatrics

Strategies for Off-label Medications for Pediatrics

References

Despite the lack of approval by the FDA on drugs to be prescribed for pediatric patients, the off-label drug is still used in healthcare. Therefore, the off-label drug is important for health issues among children, infants, and adolescents and is used for medical conditions that are not approved to treat (Scolle et al., 2021). The paper examines the rate at which the off-label drug is prescribed in children and explains the factor that influences its prescription for children with ADHD.

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The Circumstance under which Children need Off-Label Prescription

Various circumstances are likely to cause off-label prescriptions for children, including a lack of clinical trials in special age groups (Garcia-Lopez et al., 2020). A child is also likely to be given an off-label drug prescription when the standard therapy fails (Garcia-Lopez et al., 2020). The drug helps in offering relief of the symptoms and cure a specific disorder.

Therefore, the circumstances leads to the violation of the pharmacological algorithm of medication. However, it is recommended that a practitioner be cautious with the medication profile before prescribing the off-label drug to children with ADHD (Scolle et al., 2021). The first step should be to evaluate the

evidence-based research study of the off-label drug. If the evidence supports that the off-label drug is efficient for the children, the practitioner should proceed with the prescription.

For instance, the off-label drug that can treat children with ADHD is guanfacine and clonidine. Guanfacine is absorbed orally and is eliminated within 17 hours of half-life (Okada et al., 2019). Guanfacine helps in regulating the behavior of the prefrontal cortex. It also enhances the network connection needed to boost the cognitive experience (Okada et al., 2019). 50 % of the drug is excreted in Renal excrete.

Clonidine is also an off-label drug that can be prescribed to children with ADHD. It helps stimulate the alpha-adrenoceptors in the brain (Joo & Kim, 2018). This leads to decreased peripheral resistance and the sympathetic outflow from the central nervous system (Joo & Kim, 2018). It is excreted through urine. The estimated half-life is 30 minutes which occurs after epidural administration.

Strategies for Making Off-Label Use and Dosage of Drug Safe for Children

The first step to making the off-label drug safer for children is by ensuring the approval of clinical trials. The clinical trials help identify the safety of off–label drugs for pediatric patients (Rosenthal & Burchum, 2021). It is also essential to evaluate the off-label drug’s side effects and advise the patient to immediately report in case of experiencing any harmful effects (Rosenthal & Burchum, 2021). It is also needed that the pharmacy sector comes up with a solution for calculating the dosage of the off-label drug for children with ADHD.

Conclusion

Some off-label drugs require extra care before prescribing them to a patient. They possess a potency to affect a child’s liver and brain, thus requiring that nurses be extra careful when prescribing off-label medication. Therefore, despite the prescription of the off-label medication counting as a prevalent practice, it is essential to ensure that one is mindful that it can cause a serious effect on a patient. The best way to make the practice safe is by conducting a clinical trial and looking for the drug’s evidence-based practice.

References

García-López, I., Vendrell, M. C. M., Romero, I. M., de Noriega, I., González, J. B., & Martino-Alba, R. (2020). Off-label and unlicensed drugs in pediatric palliative care: a prospective observational study. Journal of Pain and Symptom Management, 60(5), 923-932. https://www.sciencedirect.com/science/article/pii/S0885392420305297

Joo, S. W., & Kim, H. W. (2018). Treatment of children and adolescents with attention deficit hyperactivity disorder and/or Tourette’s disorder with clonidine extended release. Psychiatry Investigation, 15(1), 90. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5795037/

Okada, M., Fukuyama, K., Kawano, Y., Shiroyama, T., Suzuki, D., & Ueda, Y. (2019). Effects of acute and sub-chronic administrations of guanfacine on catecholaminergic transmissions in the orbitofrontal cortex. Neuropharmacology, 156, 107547. https://www.sciencedirect.com/science/article/pii/S0028390819300620

Rosenthal, L. D., & Burchum, J. R. (2021). Lehne’s Pharmacotherapeutics for Advanced Practice Nurses and Physician Assistants. Elsevier.

Scholle, O., Kollhorst, B., Riedel, O., & Bachmann, C. J. (2021). First-time users of ADHD medication among children and adolescents in Germany: an evaluation of adherence to prescribing guidelines based on claims data. Frontiers in Psychiatry, 12, 430. https://doi.org/10.3389/fpsyt.2021.653093

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.

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.

Submission and Grading Information

To submit your completed Assignment for review and grading, do the following:

Please save your Assignment using the naming convention “WK11Assgn+last name+first initial.(extension)” as the name.
Click the Week 11 Assignment Rubric to review the Grading Criteria for the Assignment.
Click the Week 11 Assignment link. You will also be able to “View Rubric” for grading criteria from this area.
Next, from the Attach File area, click on the Browse My Computer button. Find the document you saved as “WK11Assgn+last name+first initial.(extension)” and click Open.
If applicable: From the Plagiarism Tools area, click the checkbox for I agree to submit my paper(s) to the Global Reference Database.
Click on the Submit button to complete your submission.

The use of off-label medications is a common practice in pediatric patients. The practice is associated with increased risk of harm to the patients because of inadequate evidence-based data on their use. Therefore, this paper examines circumstances that may lead to off-label prescribing to pediatric patients and safety strategies to be considered.

Circumstances

There are circumstances under which children should be prescribed off-label medications. One of them is a situation where the healthcare providers are managing unapproved disorder that does not have approved medications. In such cases, physicians prescribe medications that have proven effective among the adult populations for a similar disorder at a lower dose. The other circumstance is when the healthcare practitioners have in-depth understanding of the pediatric patients’ disease process and the effectiveness of off-label drugs.

They prescribe off-label medications to benefit the patients while utilizing their professional judgment to improve the care outcomes in pediatric patients (van der Zanden et al., 2021). For example, physicians prescribe ketamine for pediatric patients admitted to the intensive care unit despite it not being a FDA-approved drug of choice for this population.

Strategies

Healthcare practitioners should consider several strategies to ensure that off-label drugs are safe for children from infancy to adolescence. One of the strategies is by relying on the existing evidence when prescribing the off-label medications. Practitioners should critique the evidence obtained from high-quality studies and use them to inform their prescription decisions when treating pediatric patients. The other strategy is by considering ethics of practice. The decisions to treat pediatrics with off-label drugs should be informed by the principles of ensuring safety, justice, and quality outcomes for the patients (García-López et al., 2020; Hoekstra & Dietrich, 2022).

The other strategy is considering the influence of patient factors such as age on the pharmacological processes of the drugs prescribed to pediatric patients. The pharmacodynamic and pharmacotherapeutic processes in adult differ from that seen in pediatric patients.

Therefore, practitioners should make decisions such as lowering the dosage and frequency of off-label medications as compared to adult doses to ensure safety and quality outcomes (Hoon et al., 2019). Some of the off-label drugs that should be prescribed with care for pediatric patients include hydromorphone, ketamine, and dexmedetomidine, which can be fatal is poorly used.

Conclusion

In conclusion, off-label medications are largely used in pediatric patients. The use is attributable to the lack of adequate data on the efficacy of different treatments for pediatric conditions. Practitioners should consider strategies for ensuring safety in the prescription of off-label medications. In addition, they should make their treatment decisions based on evidence-based data and guidelines.

References

García-López, I., Cuervas-Mons Vendrell, M., Martín Romero, I., de Noriega, I., Benedí González, J., & Martino-Alba, R. (2020). Off-label and unlicensed drugs in pediatric palliative care: A prospective observational study. Journal of Pain and Symptom Management, 60(5), 923–932. https://doi.org/10.1016/j.jpainsymman.2020.06.014

Hoekstra, P. J., & Dietrich, A. (2022). First do no harm: Use off-label antipsychotic medication in children and adolescents with great caution. European Child & Adolescent Psychiatry, 31(1), 1–3. https://doi.org/10.1007/s00787-022-01950-7

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), e20190896. https://doi.org/10.1542/peds.2019-0896

van der Zanden, T. M., Mooij, M. G., Vet, N. J., Neubert, A., Rascher, W., Lagler, F. B., Male, C., Grytli, H., Halvorsen, T., de Hoog, M., & de Wildt, S. N. (2021). Benefit-risk assessment of off-label drug use in children: The bravo framework. Clinical Pharmacology & Therapeutics, 110(4), 952–965. https://doi.org/10.1002/cpt.2336

Case Study

A 46-year-old, 230lb woman with a family history of breast cancer. She is up to date on yearly mammograms. She has a history of HTN. She complains of hot flushing, night sweats, and genitourinary symptoms. She had felt well until 1 month ago and presented to her gynecologist for her annual GYN examination and to discuss her symptoms.

She has a history of ASCUS about 5 years ago on her pap; other than that, Pap smears have been normal. Home medications are Norvasc 10mg QD and HCTZ 25mg QD. Her BP today is 150/90. She has regular monthly menstrual cycles. Her LMP was one month ago.

Treatment Regimen

After analyzing the symptoms, I concluded that the patient is experiencing peri-menopausal symptoms. For many people, menopause begins around age 45 though the onset of symptoms varies across different people. She is undergoing the early stages of menopause which is a stage that begins with experiencing changes in the uterus, breasts, increased fat deposit, and the urogenital tract undergoing several changes such as a shrinking cervix, and reduced muscle tone in the pelvic area. At that age, the level of estrogen production is low hence, leading to hot flashes and night sweats.

Therefore, her treatment regime will focus on taking into consideration the patient has Hypertension already. Hormone therapy will be eliminated and prescribe vaginal cream that would help her manage genitourinary symptoms such as vaginal dryness and dyspareunia (Yoo et al., 2020). Mood changes and hot flashes are common symptoms of menopause hence the patient will be prescribed low-dose antidepressants such as venlafaxine and sertraline. Besides, herbal treatment has been proven to be effective in managing vasomotor symptoms hence the patient can be prescribed black cohosh which helps in reducing many menopausal symptoms (Mahady, et al., 2002).

As people continue to age, their bones become weak and this increases their chances of suffering born fractures. Therefore, the patient will be given vitamin D supplements to the increase production of estrogen which reduces with age and reduces cases of bone fractures.

During the clinical interview, I realized that the patient is taking Norva

OFF-LABEL DRUG USE IN PEDIATRICS NURS 6521