Off-Label Medication Use in Children Discussion Paper

NURS 6521 Assignment

Circumstances of use off-label drugs

Off-label drug use refers to use of medications outside the licensed indications with respect to age, route, dosage and indication. In the paediatric population, there is insufficient data pertaining to the efficacy, dosing and safety of medications as compared to adults (Gore et al., 2017). The relative lack of data is associated with factors such as; ethical considerations when conducting paediatric research, unfamiliarity with the pharmacology of paediatric population and financial constraints. Off-Label Medication Use in Children Discussion Paper

According to the American Academy of Paediatrics, when choosing to prescribe a drug that has no paediatric labelling, the prescriber must depend on their best judgement and use the best evidence available. Some of the resources that can be used for safety include; peer reviewed literature, FDAs med watch program, AAP policies and practice guidelines, consensus statements and others. The prescriber can also rely on their own and their colleagues expertise (Allen et al., 2018).  According to Corny et al., (2016), examples of off-label drugs include; albuterol in treatment of asthma, sildenafil for management of pulmonary hypertension, high dose amoxicillin in treatment of otitis media in children, antihistamine and various classes of antibiotics for respiratory infections.

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Strategies to make off-label drugs safe

Health care providers are encouraged to provide adequate information to the patients and families and engage them more closely in the decision making process. In addition, the off-label drug needs to be approved by the ethics committee, monitor for any adverse drug reaction and formulate a data base of off-label drugs and update regularly (Yackey et al., 2019). The off-label drug should be assessed by the expert group of off-label drug use before administration. Health care providers are encouraged to help build the paediatric population evidence for drugs by publishing or presenting their experiences once they routinely prescribe a drug. Off-Label Medication Use in Children Discussion Paper

Off-label drugs that require extra care

Sedatives should be used with caution in neonates since the drug might affect the growing brain. According to Oshikoya et al., (2018), fentanyl is used as an analgesic, however, it is associated with respiratory depression.

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. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6677268/

Corny, J., Bailey, B., Lebel, D., & Bussières, J.-F. (2016). Unlicensed and off-label drug use in paediatrics in a mother-child tertiary care hospital. Paediatrics & Child Health, 21(2), 83–87. https://doi.org/10.1093/pch/21.2.83

Gore, R., Chugh, P. K., Tripathi, C. D., Lhamo, Y., & Gautam, S. (2017). Pediatric Off-Label and Unlicensed Drug Use and Its Implications. Current Clinical Pharmacology, 12(1). https://doi.org/10.2174/1574884712666170317161935

Oshikoya, K. A., Wharton, G. T., Avant, D., Van Driest, S. L., Fenn, N. E., Lardieri, A., Doe, E., Sood, B. G., Taketomo, C., Lieu, P., Yen, L., & McMahon, A. W. (2018). Serious Adverse Events Associated with Off-Label Use of Azithromycin or Fentanyl in Children in Intensive Care Units: A Retrospective Chart Review. Pediatric Drugs, 21(1), 47–58. https://doi.org/10.1007/s40272-018-0318-9

‌ Yackey, K., Stukus, K., Cohen, D., Kline, D., Zhao, S., & Stanley, R. (2019). Off-label Medication Prescribing Patterns in Pediatrics: An Update. Hospital Pediatrics, 9(3), 186–193. https://doi.org/10.1542/hpeds.2018-0168

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4557722/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5736254/
http://cdn-media.waldenu.edu/2dett4d/Walden/NURS/6521/05/mm/decision_trees/week_02/index.html Off-Label Medication Use in Children Discussion Paper

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. Off-Label Medication Use in Children Discussion Paper