Off-label Drugs in Pediatrics Assignment

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Off-label Drugs in Pediatrics Assignment

Circumstances Under which Off-label Drugs may be Used in Pediatrics

Off-label drugs are medications prescribed for managing conditions in pediatrics for conditions which have not been naturally labeled for use in managing these disorders. In addition, these agents may be used in non-FDA-approved scenarios, which depend on the physician’s clinical judgment and available evidence, with the goal of providing the best possible care for the child. Research by Meng et al. (2022) recommends that off-label medications may be used in managing rare conditions that may affect the pediatric population and warrant the implementation of pharmacological intervention. Off-label Drugs in Pediatrics Assignment

The strategy may be used in managing conditions in pediatric populations that still need to have approved formulations for managing the issues and needs for which the drug has not been tested and approved for use. However, the existing evidence-based approaches may recommend the use of these agents in managing various pediatric healthcare needs (Rosenthal & Burchum, 2021). Furthermore, off-label treatments may also be used to adjust dosage and formulations where the pediatric-appropriate formulations are no longer available. Some of the off-label use agents for pediatric populations include tricyclic antidepressants for enuresis, propranolol for infantile hemangiomas, and antipsychotic agents for autism spectrum disorder. Off-label Drugs in Pediatrics Assignment

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Strategies for Enhancing the Safety of Off-label Medications from Infancy to Adolescence

Belayneh et al. (2022) demonstrate that when using these agents to manage various pediatric healthcare needs, the nurse practitioner must implement strategic approaches and mechanisms to achieve the best outcomes by promoting safety and optimizing therapeutic outcomes associated with the medication. The process requires evaluating data from reliable guidelines and evidence-based practice to ensure that these treatments are effective in attaining the desired quality of care. In addition, the nurse practitioner must apply a collaborative approach with the rest of the healthcare team members, ensure close patient monitoring for adverse effects, and promote shared decision-making (Lee et al., 2023). Furthermore, conducting continuous research is vital to establishing drug safety measures, promoting safe dosage adjustments, and reporting adverse effects or unexpected effects. Therefore, the process requires collaboration and coordination of services with the patient, family, and multidisciplinary team members. For instance, when using antipsychotics, beta-blockers, and antihypertensives, the nurse practitioner must ensure that extra safety considerations are established for the patient to achieve the desired effects. Off-label Drugs in Pediatrics Assignment

References

Belayneh, A., Abatneh, E., Abebe, D., Getachew, M., Kebede, B., & Dessie, B. (2022). Off-label medication use in pediatrics and associated factors at public hospitals in east Gojjam zone, Ethiopia. SAGE Open Medicine, 10, 205031212210965. https://doi.org/10.1177/20503121221096534

Lee, S., Yang, M. H., Kim, J. S., Cho, Y., Choi, N., Cho, E. J., Park, J. D., Choi, Y. H., & Choi, K. H. (2023). Evaluation of off-label medication use and drug safety in a pediatric intensive care unit. Saudi Pharmaceutical Journal, 31(9), 101704. https://doi.org/10.1016/j.jsps.2023.101704

Meng, M., Zhou, Q., Lei, W., Tian, M., Wang, P., Liu, Y., Sun, Y., Chen, Y., & Li, Q. (2022). Recommendations on off-label drug use in pediatric guidelines. Frontiers in Pharmacology, 13(13). https://doi.org/10.3389/fphar.2022.892574

Rosenthal, L. D., & Burchum, J. R. (2021). Lehne’s pharmacotherapeutics for advanced practice nurses and physician assistants. Elsevier. Off-label Drugs in Pediatrics Assignment

NURS 6521 WEEK 11 ASSIGNMENT INSTRUCTIONS

TOPIC: 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.

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. Off-label Drugs in Pediatrics Assignment

 

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. Off-label Drugs in Pediatrics Assignment

 

REQUIRED READING/WEEKLY RESOURCES

  • Rosenthal, L. D., & Burchum, J. R. (2021). Lehne’s pharmacotherapeutics for advanced practice nurses and physician assistants(2nd ed.) St. Louis, MO: Elsevier.
    • Chapter 9, “Drug Therapy in Pediatric Patients” (pp. 58—60)
  • 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 childrenLinks to an external site.. The Journal of Pediatric Pharmacology and Therapeutics, 22(6), 423–429. doi:10.5863/1551-6776-22.6.423

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. Off-label Drugs in Pediatrics Assignment

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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PLEASE USE SUBHEADINGS/PARAGRAPHS Off-label Drugs in Pediatrics Assignment