Assignment: Off-Label Drug Use in Pediatrics NURS 6521

Assignment: Off-Label Drug Use in Pediatrics NURS 6521

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

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

Off-Label Drug Use in Pediatrics

Off-label use refers to prescribing a drug that is not within the terms of the product license with regard to indication, dose, route of administration, or age. Children should be prescribed drugs for off-label use only in the circumstance that there is substantial evidence from well-controlled research studies supporting the drug’s efficacy in treating a particular condition in the pediatric population (Mei et al., 2017).

In addition, children should be prescribed drugs for off-label use if the indicated drugs are ineffective in treating a condition. Besides, the benefits of the drug should outweigh the potential risks. Therefore, informed consent must be obtained from the child’s parent/caregiver. The clinician should explain to the caregiver the potential benefits and risks of the drug and alternative options to off-label use (Corny et al., 2015).

Off-label use and dosage of drugs can be safer for pediatric populations by making clinical decisions guided by the best available evidence. Assignment: Off-Label Drug Use in Pediatrics NURS 6521. Besides, clinicians should prioritize the individual patient’s well-being when making clinical decisions. Clinicians should also apply their professional knowledge and judgment in determining the utilization of a drug in children (Panther et al., 2017).

In situations of off-label drug use, clinicians can play a significant role in promoting the safety of the practice by publishing their experience with the drugs they prescribed for off-label use. Furthermore, drug use studies in pediatrics should be continuously conducted to establish drug use patterns in children and suggest modifications wherever needed.

Off-label drugs that need caution and attention when prescribed in children include those targeting the cardiovascular and neurological systems and sedatives. The drugs have the risk of cardiopulmonary and neurologic instability if given in low or high doses (Allen et al., 2018). The drugs include Dopamine, Milrinone, Amlodipine, Lisinopril, lorazepam, ketamine, dexmedetomidine, fentanyl, methadone, hydromorphone, and oxycodone.

References

Allen, H. C., Garbe, M. C., Lees, J., Aziz, N., Chaaban, H., Miller, J. L., Johnson, P., & 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. Assignment: Off-Label Drug Use in Pediatrics NURS 6521.

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.

Mei, M. E. I., Li-bo, W. A. N. G., En-mei, L. I. U., Zhi-ping, L. I., Zhuo-yao, G. U. O., Xiao-bo, Z. H. A. N. G., & Hong, X. U. (2017). Current practice, management and awareness of pediatric off-label drug use in China-A questionnaire based cross-sectional survey. Chinese Journal of Evidence-Based Pediatrics, 12(4), 289. https://doi.org/10.1186/s12887-019-1664-7

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

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.

Children even respond differently during stages from infancy to adolescence. This poses potential safety concerns when prescribing drugs to pediatric patients. Assignment: Off-Label Drug Use in Pediatrics NURS 6521. 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. Assignment: Off-Label Drug Use in Pediatrics NURS 6521. 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.

Click here to ORDER NOW FOR AN ORIGINAL PAPER ASSIGNMENT: Assignment: Off-Label Drug Use in Pediatrics NURS 6521 

Your discussion was very insightful. Just to piggyback on what you said, the patient is probably experiencing premenopausal symptoms evident by hot flash, night sweats, and genitourinary symptoms. According to Smail et al. (2019), menopause is the period from when a woman has stopped menstruating for a period of twelve conservative months.

Smail 2019 explains that during this time there is drop in the production of the ovarian hormones’ estrogen and progesterone leading symptoms and diseases like vaginal infections, increased risk for osteoporosis and cardiovascular diseases, sleep disorders, mood alterations, hot flashes, depression, and urinary tract infections. Roberts & Hickey (2016) also discusses that during menopause common findings such as genitourinary syndrome of menopause, sleep disturbances, vasomotor symptoms (VMS), and mood disturbances are common.

Treatment Regimen Choice or Pharmacotherapeutics Recommendation

To control the patient blood pressure and the patient’s obesity, I will encourage patient to keep to current medication prescription regimen, make lifestyle changes, and monitor blood pressure reading regularly. VMS treatments would be based on how disturbing the symptoms are (Roberts & Hickey, 2016). Currently the most effective treatment for VMS is moderate dose estrogen-containing hormone therapy (HT), and that also improves vaginal dryness (Roberts & Hickey). They also explain that to help reduce VMS, SSRI such as escitalopram is a reasonable first choice since it is well tolerated.

I will prescribe transdermal estradiol patch, spray, or gel. The patch will be applied to the skin of the trunk, or the spray to apply once daily to the forearm or the gel to apply once daily to one arm, from the shoulder to the wrist or to the thigh (Rosenthal & Burchum, 2018). when used for VMS, escitalopram reduces the frequency, severity and improves quality of life, improves sleep, and does not cause sexual dysfunction (Rosenthal & Burchum). Transdermal formulations range of estrogen absorption is from 14 to 60 mcg/24 hr, depending on the product employed (Rosenthal & Burchum).

Patient Education Strategy Recommendation

To help with the patient’s VMS, I will educate the patient on eating heart healthy food such as whole grains, vegetables, fruits, and maintain a normal level of vitamin D and Calcium (McCance & Huether, 2019). To manage the patient’s weight, I will encourage her to reduce the amount of processed foods, reduce salt intake, avoid or limit alcohol consumption, maintain a healthy weight, manage stress level and regular exercise weekly at least for thirty minutes daily (McCance & Huether).

Maintain good sleep pattern by avoiding caffeine, engage in bedtime relaxation rituals such as stay away from bright lights to reduce things that can cause excitement before bedtime and avoid eating large meals for at least two hours before bedtime (Fujimoto, 2017). Fujimoto also explains that keeping to regular health maintenance such as pap smear test, mammograms, breast self-examination, cholesterol screening. Also, I will encourage the patient to take flu shot annually.

References

Fujimoto, K. (2017). Effectiveness of coaching for enhancing the health of menopausal Japanese women. Journal of Women & Aging, 29(3), 216–229. https://doi-org.ezp.waldenulibrary.org/10.1080/08952841.2015.1137434

 McCance, K. L. & Huether, S. E. (2019). Pathophysiology: The biologic basis for disease in adults and children (8th ed.). St. Louis, MO: Mosby/Elsevier. 

Rosenthal, L. D., & Burchum, J. R. (2018). Lehne’spharmacotherapeutics for advanced practice providers. St. Louis, MO: Elsevier.

Roberts H., & Hickey, M. (2016) managing the menopause: An update. Maturitas, 86(2016), 53-58. Retrieved from https://www-sciencedirect-com.ezp.waldenulibrary.org/science/article/pii/S037851221630007X?via%3Dihub

Smail, L., Jassim, G., & Shakil, A. (2019). Menopause-Specific Quality of Life among Emirati Women. International Journal of Environmental Research and Public Health, 17(1). https://doi-org.ezp.waldenulibrary.org/10.3390/ijerph17010040

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Module in Review

In this module, you evaluated the practice and circumstances of prescribing off-label drugs to children and analyzed the strategies used to make their use and dosage safer for children. After you have completed the Discussion and the Final Exam for this week, you have finished the course. Assignment: Off-Label Drug Use in Pediatrics NURS 6521.  Congratulations! Please complete the Course Evaluation form and submit by Day 7.

Congratulations! After you have finished all of the assignments for this week, you have completed the course. Please submit your Course Evaluation by Day 7.

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

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.

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

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

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