Assingnment: Unapproved Use of Approved Drugs For Pediatric Patients Essay

Assignment: Unapproved Use of Approved Drugs For Pediatric Patients Essay

Assignment: Unapproved Use of Approved Drugs For Pediatric Patients Essay

Assignment: Unapproved Use of Approved Drugs For Pediatric Patients Sample Essay

            While there is a wealth of information readily accessible on adult medication, studies on the use of the same medications in children are scarce. According to studies, the majority of drugs prescribed by doctors have not been subjected to clinical trials in pediatrics to establish their effectiveness and safety for approval by the FDA (Yackey et al., 2019). As a result, practitioners have no choice but to prescribe certain medications for off-label or unapproved use in children. The primary goal of this discussion is to describe the circumstances surrounding the unapproved use of FDA-approved drugs in pediatric patients.

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Reasons for Using Off-Label Drugs in Pediatrics

            A variety of variables contribute to the use of off-label medications in the pediatric population. One of the primary reasons is the lack of standard, certified, effective, and safe therapeutic options for the treatment of certain diseases in children and adolescents, like depression. Another instance in which off-label medications may be explored is when normal therapy fails to elicit the intended result in the patient when compared to the efficacy of other non-approved drugs (Tanemura et al., 2019). For example, if a kid has a significant depressive illness, a doctor will be required to utilize medications like SSRIs (fluoxetine), which are licensed for adults but lack strong data on their safety and efficacy in children.

Approaches to Ensure the Safety of Off-Label Drug Use and Dosage

            Young’s and Clark’s guidelines are two empirical approaches often used to determine the dose of the children and adolescent population to encourage the safe use of off-label medications in this age group (Balan et al., 2018). These methods are effective and safe for use in the pediatric population, ranging from infancy to adolescence. However, new research is being conducted to ensure that evidence-based practice is included in pediatric medicine. The FDA has identified roughly 10 pharmaceutical agents that should be used with extreme caution in children and adolescents, including Risperdal, Seroquel, Zyprexa, Celebrex, coumadin, and Singulair among others that increase risks of suicidal ideation in this age group.

Conclusion

            Unapproved use of Authorized drugs in the pediatric population is completely permissible, if not vital, considering the limited licensed medication available for this group in controlling common problems such as depressive disorder. Even though few studies have been undertaken to assess the safety and efficacy of such medicine in the pediatric population. Professional organizations and committees have developed emergency procedures that may be utilized to assure the safe use of adult medication in children.

References

Balan, S., Hassali, M. A. A., & Mak, V. S. (2018). Two decades of off-label prescribing in children: a literature review. World Journal of Pediatrics, 14(6), 528-540 ttps://doi.org/10.1007/s12519-018-0186-y

Tambura, N., Asawa, M., Kuroda, M., Sasaki, T., Iwane, Y., & Urushihara, H. (2019). Pediatric off-label use of psychotropic drugs approved for adult use in Japan in the light of approval information regarding pediatric patients in the United States: a study of a pharmacy prescription database. World Journal of Pediatrics, 15(1), 92-99. DOI: 10.1007/s12519-018-0213-z.

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

 

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.

Reflect on situations in which children should be prescribed drugs for off-label use.

Explain the circumstances under which children should be prescribed drugs for off-label use. Be specific and provide examples.
Explain strategies to making off-label use and dosage of drugs safer for children from infancy to adolescence and descriptions and names of off-label drugs that require extra care and attention when used in pediatrics. Be specific.