Fill in order details

  • Submit your instructions
    to writers for free!

Chat with the writer

  • Chat with preferred expert writers
  • Request a preview of your paper
    from them for free

Editing

  • Project edited by the quality evaluation department

Download Your Completed Project

  • Download the completed project from your account or have it sent to your email address

[SOLVED] Explain the circumstances under which children should be prescribed drugs for off-label use

Explain the circumstances under which children should be prescribed drugs for off-label use

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.

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.

Expert Answer and Explanation

Off-Label Drug Use in Pediatrics

Off-label refers to the utilization of drugs that are not included in the approved labeling package of that specific drug (Frattarelli et al., 2014). The main reason for using off-label is solely for the benefit of a patient in the event that existing labeled drugs are inefficient. Be that as it may, off-label is not an implication to an illegal, improper, investigational, or contraindicate the use of a drug; rather, it is a legal, operational drug that is pending approval by the FDA (Gore et al., 2017). There are various circumstances within which children should be prescribed with off-label drug use.

Circumstances to Allows Off-Label use in Children

According to the American Academy of Pediatrics (AAP) (2014), there are less than half of existing medication that provides specific labeling for young children and infants. This implies that a pediatrician has to make decisions based on their intuition and clinical judgment on the appropriate prescription dosage (Yackey et al., 2019). Accordingly, the main circumstance that a pediatrician has to offer off-label drug prescription is because there is an overwhelming number of critically essential medications that do not have labeling information regarding their usage in children (American Academy of Pediatrics, 2014). This is a major concern mainly due to the different yet special populations of children ranging from children with rare or chronic diseases, preterm infants, and newborns.

The absence of required labeling of drugs to be used with a specific age illness or age set is not an inference that the overall use of the drug if flawed or improper to the children. In retrospect, it only indicates that the FDA is yet to approve the present evidence required by law that allows the inclusion of the label to the drug (Gore et al., 2017). A pediatrician is allowed to make decisions based on expert opinion, and the lack of labeling in specific drugs does not signify that therapy cannot be supported on collected data or professional experiences. In contrast, the lack of labeling only means that the manufacturer or supplier of the drug has to submit evidence to the FDA for approval.

Making Off-Label Drugs Safer

There are various strategies that are put in place to make the off-label use and dosage of drugs safer for children uptake from infancy up to their adolescent stages (Yackey et al., 2019). To make up for the lack of labels, some drugs indicate on their packages that the drug is yet to meet the required tests and approvals to ascertain the safety and efficacy in pediatric patients (Frattarelli et al., 2014). Other drugs provide explicit and vivid evidence-based warnings, including any contradictions where the label is indicated. It is the mandate of the pediatrician to comprehend the distinction between the contradictions or explicit warning against the use of the drug versus the lack of labeling or FDA approval for a specific dosing regimen or use (Gore et al., 2017). As such, the understanding of the information relating to pediatric use is essential and a form of best practice for making therapeutic decisions.

In conclusion, there is a need to understand that the FDA does not in any way regulates the utilization of drugs as pertains to medical practice. Pediatricians can recommend the prescription of off-label use drugs to children patients based on their expert opinion. The absence of labels does not signify the improper or illegal use of medication, rather insufficient evidence required by law to authenticate or approve the use of medication in children. However, pediatricians should only make use of off-label drugs only on the circumstance that the existing label drugs are not effective in providing the required output.

References

American Academy of Pediatrics. (2014). AAP Makes Recommendations On Use of Off-Label Drugs for Children. aap.org. Retrieved 20 April 2020, from https://www.aap.org/en-us/about-the-aap/aap-press-room/pages/AAP-Makes-Recommendations-On-Use-of-Off-Label-Drugs-for-Children.aspx

Frattarelli, D. A., Galinkin, J. L., Green, T. P., Johnson, T. D., Neville, K. A., Paul, I. M., & Van, J. D. A. (2014). Off-label use of drugs in children. Pediatrics133(3), 563-567. https://doi.org/10.1542/peds.2013-4060

Gore, R., K Chugh, P., D Tripathi, C., Lhamo, Y., & Gautam, S. (2017). Pediatric off-label and unlicensed drug use and its implications. Current clinical pharmacology12(1), 18-25.

Yackey, K., Stukus, K., Cohen, D., Kline, D., Zhao, S., & Stanley, R. (2019). Off-label medication prescribing patterns in pediatrics: an update. Hospital pediatrics9(3), 186-193.

Place your order now for the similar assignment and get fast, cheap and best quality work written by our expert level  assignment writers.Explain the circumstances under which children should be prescribed drugs for off-label use

Use Coupon Code: NEW30 to Get 30% OFF Your First Order

ANSWERED! 67-year-old female presents with chief complaint

SOLVED! Healthcare continues to be a lucrative target for

SOLVED! Post a brief explanation of the differences between

SOLVED!! Explain how interprofessional collaboration will

SOLVED! Mr. EBR is a 74-year-old retired Hispanic gentleman

ANSWERED!! Identify your role as a health care professional in supporting Abby’s or Shanti’s dying rituals

ANSWERED!! Explain how personal and business ethics can be subconsciously overridden in decision-making. Does your selected business exemplify this?

ANSWERED!! What parts of the lawmaking process does a nurse have an opportunity to influence the final bill passage?

[ANSWERED] Pakistani Woman with Delusional Thought Processes

[ANSWERED] Create your own script for building a health history and use the Health History Template for guidance (consider the type of language you would use to help your patient be more comfortable).

[ANSWERED] Assessing the Genitalia and Rectum

[ANSWERED] Explain how you would advocate for the

What our customers say
_____

  • Essay was good; although need to do few amendments and add few things, overall it was good and justify money paid.

     

    FinanceProfessional assignment help services
  • it was good
    it has introduction, body paragraphs, and conclusion as well
    it was really helpful

    PsychologyProfessional assignment help services
  • Great service. Always provide quick response and best online support and have very very less plagiarism.

    EconomicsProfessional assignment help services
  • Thanks for giving my assignment on time. I really appreciated the work done. This keeps me submitting new assignments.

    HealthcareProfessional assignment help services
  • Thank you my writer. Good job and I really enjoy you fast response. I definitely will recommend to my friends.

     

    NursingProfessional assignment help services
  • Thanks for giving my assignment on time. I really appreciated the work done. This keeps me submitting new assignments.

    NursingProfessional assignment help services
  • Great service. Always povide quick response and best online support and have very very less plagiarism.

     

    Business LawProfessional assignment help services
  • Good writer that fulfil all the requirements that i have been told to the writer. The writer even called to discuss everything with me to continue my assighnment

     

    FinanceProfessional assignment help services
  • Great work on time delivered for work, good understanding well prepared. References was well written in APA format

    NursingProfessional assignment help services
  • The writer had clear communication and ensured to give me a brief overview of how my assignment was going to be structured including an average of the words used in each section in order to avoid going over the limit. Didn't need to escalate even once because the quality of the work was in line with the Standard quality that I chose.

    AccountingProfessional assignment help services
  • It was okay. Not bad, could do better! But marks were good, feedback was also good, so overall 4/5

     

    ProgrammingProfessional assignment help services
  • The solution was excellent and all the requirements was taken into consideration.

    ChemistryProfessional assignment help services
  • On time and the assisgment is veryy well done. thank you very much. i'm happy and this is not the last time of me getting help

     

    ManagementProfessional assignment help services
  • This is solid work thankyou for all the help with this PowerPoint; I m curious what grade ill get in it

     

    NursingProfessional assignment help services
  • Great Work Completed in under a Hour thank you so much. I got a 100 percent on my assignment.

    NursingProfessional assignment help services
  • I got 87%. Thanks for that. I am quite satisfied as You reviewed and changed when I ask for some changes.

     

    ChemistryProfessional assignment help services
  • I got a Distinction in this course. Highly satisfied with the expert work and effort.

     

    Business LawProfessional assignment help services
  • I am very happy with this assignment. Thank you very much to the expert who has done this for me.

     

    Business LawProfessional assignment help services
  • So far this is the highest marks I got for an assignment done by you guys. I got 42/50 for this assignment. The exact feedback from my lecturer was:
    Introduction: Good introduction to assisted dying, especially in relation to laws within Australia. Introduction was a little too long.
    Aim or Purpose: Good purpose but improved grammar needed. Good use of PICO.
    Method: The method, while explained is very out of order. Try to write a methods section that can be followed in a step by step fashion

    NursingProfessional assignment help services
  • You did a good job just some details were missed enough attention. To be honest, you did much better job than the other websites. I would like to have more experience with you then I can give you more detailed feedback.

     

    ManagementProfessional assignment help services

You cannot copy content of this page