Sample Answer for NURS 6521 Assignment: Off-Label Drug Use in Pediatrics Included After Question
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.
A Sample Answer For the Assignment: NURS 6521 Assignment: Off-Label Drug Use in Pediatrics
Title: NURS 6521 Assignment: Off-Label Drug Use in Pediatrics
Off-label use is when a drug is used for an unapproved age group, an unapproved sign, an unapproved type of organization, or an unapproved dose that is not approved by the appropriate public authority, just as unlicensed use is when a prescription is used for a purpose that is not approved by the appropriate public authority. Off-label usage is generally legal, unless when it violates safety or moral standards; however, it introduces health risks and changes in legal liability. Additionally, the conditions under which off-label drug use should be encouraged for children include the absence or inaccessibility of authorized, standard, safe, and practical restorative options for a specific ailment or illness in children, as well as conflicting/absence of paediatric evidence in SmPC. Several distinct scenarios include standard treatment failure, for explicit age groups requiring elective sorts of treatment, and the absence of clinical prerequisites in explicit age groups such as infants, children, the elderly, and pregnant women, among others. (2016) (Mir & Geer).
Strategies to create it safer to drug dose and off-label use for youngsters includes:
Prescribing Appropriate Medicines
Drugs should, therefore, be used with the right dosages for the correct duration in the greatest rational way. While pediatrics is very well discipline, family doctors who may not have provided well-advanced training in this area treat most children in healthcare. This has caused the wrong diagnosis and misuse of antibiotics and other drugs. NURS 6521 Assignment: Off-Label Drug Use in Pediatrics
Designing Enhanced Pediatric Preparations
Various definitions basic for every development, which would deal with drug consistence, digestion, drug organization timing, and drug use responses.
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Improving Drug Compliance
Smell, taste, consistency, color, cost, and dosing frequency affect the compliance of the patient with the drug treatment. The spitting of
nasty medications is common amid younger children and infants. Compliance must be improved with precise drug medicine and also correct caretakers counseling managing the drug.
Educating Caretakers and Parents
In the Indian community, self-medication through parents on the recommendation of friends or relatives, traditional medicines, or another over-the-counter drug not supervised by a healthcare professional is common (Dharmapalan, 2012)
The off-label drugs which need extra attention and care are Salbutamol, Amoxicillin, and Cyclizine.
Salbutamol utilized in the COPD and “asthma treatment” is a choosy short-acting beta2-adrenergic receptor agonist. It relaxes the muscles in the lungs, small air passages walls. This supports to open the airlines and assistances relieve puffed cough, and chest tension to easily respire. It’s named a reliever drug or “short-acting” bronchodilator. NURS 6521 Assignment: Off-Label Drug Use in Pediatrics
Amoxicillin prescribes by the doctor if the child has a bacterial infection and also recommends its dosage. This drug is an antibiotic that is prescribed and used to treat various bacterial infections.
Cyclizine is an antihistamine piperazine-subsidiary utilized as an antiemetic/antivertigo specialist. In the therapy and anticipation of heaving, queasiness, and wooziness related to movement ailment, it is utilized. These tablets aren’t recommended for less than six years of age children.
References
Dharmapalan, V. N. (2012). Promoting the appropriate use of drugs in children. International Journal of Pediatrics. Retrieved from https://www.hindawi.com/journals/ijpedi/2012/906570/
Mir, A. N., & Geer, M. I. (2016). Off-label use of medicines in children. IJPSR, 7(5), 1820-1828. Retrieved from https://1library.net/document/q7613ery-off-label-use-of-medicines-in-children.html#pdf-content. NURS 6521 Assignment: Off-Label Drug Use in Pediatrics
A Sample Answer 2 For the Assignment: NURS 6521 Assignment: Off-Label Drug Use in Pediatrics
Title: NURS 6521 Assignment: Off-Label Drug Use in Pediatrics
Off-label drug use refers to prescribing an FDA-approved drug for non-indicated use. Clinicians usually prescribe a drug for an unapproved use after they deem it medically appropriate for a specific patient. The purpose of this paper is to explore off-label drug use in pediatrics.
Circumstances to Prescribed Drugs for Off-Label Use in Children
Drugs should be used for off-label use in children if there is evidence supporting the drug’s efficacy and safety in treating the specific condition in pediatrics. The drug should have been evaluated by the expert group on off-label drug use and approved by the pharmacy administration committee (Meng et al., 2022). Most importantly, the benefits of off-label use should outweigh the risk for pediatric patients. For instance, the clinician should assess the potential benefits and risks of prescribing the drug to a child and ensure that the benefits outweigh the risks (Rusz et al., 2021). The clinician should also prescribe a drug for off-label use after obtaining informed consent from the caregiver and making a plan for monitoring adverse drug reactions (ADRs).
Strategies to Make the Off-Label Use and Dosage of Drugs Safer For Children
Off-label use can be made safer for pediatrics by ensuring that their recommendations in pediatric guidelines are founded on a reliable methodological framework. An off-label drug database can be established and updated regularly, where clinicians can refer to it before prescribing to identify potential benefits and ADRs, promoting patient safety (Meng et al., 2022). Providing information on the risks of off-label drugs can encourage health providers to appropriately prescribe and use off-label medications for pediatrics. Off-label medications requiring extra care and attention in pediatrics include cardiovascular system drugs (Amlodipine, dopamine), sedatives (lorazepam, ketamine), fentanyl, oxycodone, and hydromorphone (Allen et al., 2018).
Conclusion
Drugs for off-label use should be prescribed in children if they are supported by evidence, evaluated by the expert group, and if the benefits outweigh the risks. Off-label use can be made safe in pediatrics by having a reliable methodological framework and a regularly updated database. Sedatives and CVS drugs should be used with caution in off-label use in children.
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.
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, 892574. https://doi.org/10.3389/fphar.2022.892574
Rusz, C. M., Ősz, B. E., Jîtcă, G., Miklos, A., Bătrînu, M. G., & Imre, S. (2021). Off-Label Medication: From a Simple Concept to Complex Practical Aspects. International Journal of Environmental Research and Public Health, 18(19), 10447. https://doi.org/10.3390/ijerph181910447
A Sample Answer 3 For the Assignment: NURS 6521 Assignment: Off-Label Drug Use in Pediatrics
Title: NURS 6521 Assignment: Off-Label Drug Use in Pediatrics
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