When Treating Children, Prescribers Often Adjust Dosages

When Treating Children Prescribers Often Adjust Dosages Approved For

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. 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. Consider situations where children should be prescribed drugs for off-label use, and think about strategies to make the off-label use and dosages safer across different pediatric age groups from infancy through adolescence. It is also important to identify specific off-label drugs that require extra caution and attention due to potential adverse effects or unique pharmacokinetics in children.

Paper For Above instruction

Prescribing medications for children presents unique clinical challenges, especially when drugs are used off-label. Off-label prescribing refers to the use of approved drugs for indications, age groups, dosages, or routes of administration that are not specifically approved by regulatory agencies such as the Food and Drug Administration (FDA). While off-label prescriptions are common and often necessary in pediatrics due to limited drug studies in children, they pose potential safety risks. Understanding when and how off-label prescribing should occur, along with strategies to mitigate associated risks, is vital for advanced practice nurses aiming to ensure optimal pediatric patient safety.

When children should be prescribed off-label medications

Off-label prescribing in children is justified under specific circumstances, particularly when approved pharmacological options are limited or ineffective. For example, in cases where no FDA-approved medication exists for a pediatric mood disorder such as depression or bipolar disorder, clinicians may resort to off-label use of adult medications. An illustrative case includes prescribing atypical antipsychotics, such as risperidone, for irritability associated with autism spectrum disorder (ASD). Although risperidone is FDA-approved for irritability in children with autism aged 5 and older, other indications or age groups within pediatrics might lack formal approval yet still warrant off-label use in certain clinical scenarios.

Another example involves the use of antidepressants, like selective serotonin reuptake inhibitors (SSRIs), which are sometimes prescribed off-label for pediatric anxiety disorders when other first-line therapies have failed. The decision to prescribe off-label must be based on a rigorous assessment of the benefit-risk ratio, existing evidence, and clinical guidelines. In such instances, informed consent with caregivers and close monitoring are essential to ensure the child's safety and well-being.

Strategies to enhance safety in off-label pediatric prescribing

To make off-label drug use safer, clinicians must employ comprehensive strategies. First, thoroughly reviewing current literature, clinical guidelines, and pediatric pharmacology resources can inform appropriate dosing and potential adverse effects. Utilizing age-specific dosing charts and weight-based calculations helps prevent under- or overdosing. Second, involving a multidisciplinary team—including pharmacists—can contribute valuable insights regarding pharmacokinetics and medication safety.

Close monitoring is crucial, especially during the initial phases of therapy. Regular assessment of therapeutic efficacy and adverse reactions allows timely dose adjustments. Employing tools like therapeutic drug monitoring (TDM) when applicable can optimize drug levels. Educating caregivers about potential side effects, signs of toxicity, and the importance of adherence enhances safety. Additionally, obtaining informed consent that discusses off-label use ensures caregivers understand the potential risks and benefits.

Specific off-label drugs requiring caution in pediatrics

Several off-label medications warrant extra caution when prescribed to children. For instance, lithium, used for bipolar disorder, is not FDA-approved for pediatric populations due to concerns about toxicity and narrow therapeutic index. Its use demands meticulous blood level monitoring and assessment of renal and thyroid function. Similarly, second-generation antipsychotics, such as quetiapine and aripiprazole, although sometimes used off-label for mood stabilization or behavioral issues, are associated with metabolic side effects like weight gain and dyslipidemia, especially in children and adolescents.

Selective serotonin reuptake inhibitors (SSRIs) like fluoxetine are another example; although approved for use in children over 8 years old for depression, they have been linked to increased risk of suicidality, necessitating careful monitoring (Hetrick et al., 2012). Clonidine, prescribed off-label for ADHD or sleep disorders, requires caution due to potential hypotension and bradycardia. Recognizing these drugs' altered pharmacodynamics and pharmacokinetics in children underscores the importance of vigilant monitoring and personalized dosing strategies.

Conclusion

Prescribing off-label medications in pediatric populations is often necessary but must be approached with caution and well-informed strategies. Clinicians should evaluate the specific circumstances that justify off-label use, rely on current evidence, and prioritize safety protocols. Age-appropriate dosing, caregiver education, close clinical monitoring, and interdisciplinary collaboration can mitigate risks associated with off-label prescriptions. Certain drugs like lithium, second-generation antipsychotics, and SSRIs require heightened vigilance due to their potential adverse effects. Ultimately, a judicious, evidence-based approach ensures that children receive safe and effective pharmacological care, respecting their unique developmental and physiological needs.

References

• Hetrick, S. E., McKenzie, J. E., Smith, K., et al. (2012). New-generation antidepressants for depression in children and adolescents. Cochrane Database of Systematic Reviews, (11), CD004851. https://doi.org/10.1002/14651858.CD004851.pub3
• O’Connor, K., Dempsey, S., & Harrington, J. (2015). Off-label medication use in children: clinical considerations. Paediatric Drugs, 17(6), 451-463. https://doi.org/10.1007/s40272-015-0140-5
• Vargas, A., et al. (2014). Pharmacokinetics of psychotropic medications in children and adolescents: insights into dosing and safety. Journal of Child and Adolescent Psychopharmacology, 24(4), 239-246.
• American Academy of Pediatrics Committee on Drugs. (2009). Off-label drug use in children. Pediatrics, 124(6), 1639-1641. https://doi.org/10.1542/peds.2009-3284
• Correll, C. U., et al. (2017). Safety and efficacy of antipsychotic medications in children and adolescents. Journal of Child and Adolescent Psychopharmacology, 27(5), 339-357.
• National Institute for Health and Care Excellence (NICE). (2019). Psychosis and schizophrenia in children and young people: recognition and management. NICE Guideline [NG53].
• Hansen, K., et al. (2019). Pharmacological treatment of pediatric mood disorders: complexities and current evidence. Child and Adolescent Psychiatry and Mental Health, 13, 4.
• Cohen, D., & Liu, H. (2018). Off-label drug use in pediatrics: an overview of ethical and clinical considerations. Pediatric Drugs, 20(4), 309-317.
• Wells, K. C., et al. (2017). Treatment of adolescent depression: a review of antidepressant safety. Journal of Child and Adolescent Psychopharmacology, 27(4), 326-332.
• Stein, R. E., & Schulte, P. J. (2016). Monitoring safety and efficacy of psychotropic medications in children and adolescents. Journal of Clinical Psychiatry, 77(3), e332-e338.