Assignment: Off-Label Drug Use in Pediatrics/ Advanced pharmacology
Pediatricians are required to use their skills, competency, and experience to ensure the effective treatment of pediatric patients. However, as Allen et al (2018) explain, there is a lack of adequate evidence regarding the dosing, safety, and efficacy of medications in the pediatric population. Consequently, off-label mediations in children are being used. This paper discusses circumstances to prescribe off-label drugs for children and strategies to ensure the safety of off-label medications in this population.
Circumstances under which children need to be prescribed off-label medications include when such a child or adolescent has a chronic condition that requires more than one kind of medication (Allen et al., 2018). This may lead to the prescription of numerous medications. Additionally, in a case where a child has a high pain level and the recommended dose does not reduce the pain score, this may lead to prescription and administration of higher doses of analgesic (Alazmi et al., 2020). For example, tramadol is an opioid analgesic that can be used off-label to relieve high pain levels in children. Another example includes bronchodilators such as albuterol are safer off-label medications to provide dosage for the treatment of asthma in the pediatric population.
One strategy is for the prescriber to closely monitor the prescribed off-label medication to monitor the tolerance, safety of the medication in order to promptly recognize any side effect or adverse effect. Prescribers also need to seek rigorous informed consent by informing parents of the patients about the probable benefits and risks of the off-label medication to ensure they understand the clinical outcome before administering the medication.
Off-label medications that need extra care and attention include antibiotics such as ceftriaxone and vancomycin. These antibiotics are administered as off-label medications to pediatrics to treat lower respiratory infections, meningitis, and sepsis. This is because over-prescription of off-label antibiotics such as ceftriaxone and vancomycin can lead to antibiotic resistance (Lizano-Díez et al., 2021).
Off-label medications may be prescribed when is specific circumstances such as when the first-line medication has been used without any efficacy. It is important for prescribers to closely monitor pediatric patients administered with off-label medications for any side/adverse effect. Prescription of off-label antibiotics such as ceftriaxone and vancomycin need to be done cautiously to avoid antibiotic resistance.
Alazmi, A., Alasmari, Z., Yousef, C., Alenazi, A., AlOtaibi, M., AlSaedi, H., … & Alahmari, M. (2020). Off-Label Drug Use in Pediatric Out-Patient Care: A Multi-Center Observational Study. Hospital Pharmacy, 0018578720942226.
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.
Lizano-Díez, I., Aldalur-Uranga, I., Figueiredo-Escribá, C., Lastra, C. F., Mariño, E. L., & Modamio, P. (2021). Effects of the Off-Label Drug Prescription in the Paediatric Population in Spain from the Adoption of the Latest European Regulation: A Pre-Post Study. Pharmaceutics, 13(4), 588.
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.
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.
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