Off-Label Drug Use in Pediatrics Discussion

A Sample Answer For the Assignment: Off-Label Drug Use in Pediatrics Discussion

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).

off-label drug use in pediatrics discussion — Off-Label Drug Use in Pediatrics Discussion

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

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Question Description

I’m stuck on a Nursing question and need an explanation.

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. 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.
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.
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Hey Ruth thanks for sharing this informative post. Menopause is a complex period of life which is associated with many physical and psychological changes and hot flushes are one of the most common bothersome symptoms related to menopause which has affected 85% of menopausal women with various frequency, severity and duration that needs to be addressed. Hormone replacement Therapy is considered one of the most effective treatments of choice to treat or manage these menopausal associated symptoms however there are exceptions that prevents its use.

One of the example is the patient condition in the given scenario is compatible with exceptions that could prevent its use from using this treatment regimen that is Hormonal Replacement Therapy as patient in the given scenario is at risk for developing breast cancer due to her family history of breast cancer and prescribing her with HRT could potentially make her more prone to developing breast cancer and hence non hormonal based treatment regimen should be considered. Some of the non-hormonal based options include use of antidepressants such as SSRIs (paroxetine) and SNRIs and other one is the use of Gabapentin and Clonidine can also be used.

Looking back at the patient scenario patient has a history of high blood pressure and is currently on amlodipine and Hydrochlorothiazide however patient still is experiencing high blood pressure and hence I believe addition of clonidine in the patient’s current drug therapy regimen, along with amlodipine and hydrochlorothiazide can be beneficial in achieving effective blood pressure control and reduction in adverse reactions. Adding Clonidine (alpha adrenergic agonist) to the drug therapy will be useful in controlling blood pressure as well as treating symptoms such as hot flashes that are related to premenopausal symptoms.

I think a lot of women; about 51% seek complementary and alternative medicine (CAM) for managing the symptoms associated with menopause as they consider it as safe and effective option with no risk associated with it, as it’s natural. However the majority of the women using CAM do not discuss it with their health care provider. Hence it is very important to reconcile their current medication list at each visit and educate patient on importance of informing their health care provider if they are using any alternative or complementary treatments such as plant estrogens, bioidentical hormones, black cohosh etc in managing their symptoms of menopause to prevent any adverse effects resulting from drug interactions.

References

Johnson, A., Roberts, L., & Elkins, G. (2019). Complementary and Alternative Medicine for Menopause. Journal of evidence-based integrative medicine, 24, 2515690X19829380. https://doi.org/10.1177/2515690X19829380

Rosenthal, L. D., & Burchum, J. R. (2021). Lehne’s pharmacotherapeutics for advanced practice nurses and physician assistants (2^nd ed.) St. Louis, MO: Elsevier.

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Rubric

NURS_6521_Week11_Assignment_Rubric

Off-Label Drug Use in Pediatrics Discussion