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NURS 6521 Week 11 Assignment - Off-Label Drug Use in Pediatrics

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Pediatric drug therapy presents difficult due to insufficient drug information available. It is not uncommon to see off-label drug use in pediatrics. Off-label drug use is using drugs for a different indication or age group than what it was approved for (Corny et al., 2015). Due to the physiological differences between adults and children, it is important to know the safety concerns related to off-label use with this population. In this assignment we will discuss circumstances in which children should be prescribed drugs for off-label use, as well as strategies to make drug dosage safer for children. Circumstances for Off-Label Drug Use Off-label drug use involves prescribing medication for purposes other than the purposes listed by the manufacturer (Aamir & Mohammad, 2021). There are certain circumstances in which children should be prescribed drugs for off-label use including the unavailability of authorized, safe treatment options for a specific illness in children, as well as evidence on their effectiveness and safety in particular situations (Aamir & Mohammad, 2021). Antihistamines, antidepressants, and antibiotics seem to be among the most common drugs that are prescribed off-label (Gordon, 2019). For example, the use of antihistamines for children with asthma is very common; although it is only indicated for allergies, it proves effective with our pediatric patients with asthma (Tefera et al., 2017). There have been instances where high doses of Amoxicillin have been used in infants for ear infections as well as Morphine to treat pain (Aamir & Mohammed, 2021). Strategies for Safer Off-Label Drug Use in Children Unfortunately, with off-label drug prescribing we run the risk of pediatric patients experiencing adverse side effects. Some strategies to make the off-label use and dosage of drugs safer for children of all ages includes creating a guideline for commonly used off-label medications, including calculated doses based on age and weight from adult doses (Doom & Killick, 2017). Another effective way to create safer off label drug use would be to appropriately label medications with an age-specific warning to raise awareness of the insufficient data available for these drugs in pediatric use. Some high-risk drugs that require extra care when used in pediatrics include dopamine, hydromorphone, lorazepam, and oxycodone (Czaja et al., 2015). These drugs require extra attention due to the unknown longer term adverse effects of use while still developing; cardiovascular medications can lead to hemodynamic instability and/ or compromised oxygen levels, and neurological medications could result in acute cardiopulmonary or neurological status changes (Czaja, et al, 2015). Conclusion Overall, pediatric patients deserve to receive safe and effective medications. Examining the potential risks and benefits with the patent’s parents and treatment team should be an open discussion to determine the most appropriate plan. With further studies and research, health care providers could have access to more beneficial treatment options for their pediatric patients. References Aamir, N. M., & Mohammad, I. G. (2021, August 12). Off-label use of medicines in children: International Journal of Pharmaceutical Sciences and Research. IJPSR. Retrieved February 8, 2022, from Corny, J., Lebel, D., Bailey, B., & Bussières, J. F. (2015). Unlicensed and Off-Label Drug Use in Children Before and After Pediatric Governmental Initiatives. The journal of pediatric pharmacology and therapeutics: JPPT : the official journal of PPAG, 20(4), 316–328. 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. The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG, 20(3), 186–196. Dooms, M., & Killick, J. (2017). Off-label use of medicines: The need for good practice guidelines. The International journal of risk & safety in medicine, 29(1-2), 17–23. Gordon, S. (2019, September 16). 'off-label' drugs for kids raises concerns. WebMD. Retrieved February 9, 2022, from 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 & perspectives, 5(2), e00304.


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