Assignment: Off-Label Drug Use in Pediatrics
Assignment 2 Off-Label Drug Use in Pediatrics
Off-Label Drug Use in Paediatrics
The Pediatric Research Equity Act and the Pharmaceuticals for Children Act were passed to collectively improve the rational prescribing of drugs for children (Nir-Neuman et al., 2018). Despite this, there is still a significant risk to the posed by the use of drugs outside of their approved indications, particularly among infants, children, and adolescents. This is due to the fact that the majority of medications still do not include information in their labels regarding their appropriate use in children. This discussion illustrates the circumstances under which clinicians can prescribe off-label drugs for pediatric patients, in addition to strategies to improve their safety.
Circumstances to Consider Off-Label Use of Drugs
There are numerous reasons a clinician can prescribe a drug off-label, especially among pediatric patients. Some of these reasons include a lack of alternative forms of treatment for this age group, standard therapy failing to elicit the desired effect, and a lack of clinical trials in neonates, infants, and children, as a result of safety issues (De Zen et al., 2018).
Situations for Making Off-Label Drug Safe among Pediatrics
Implementing evidence-based practice in prescription practice by generating more quality pieces of literature on the effectiveness and safety profile of off-label drugs will improve their use in the pediatric population. For safe dosing of off-label drugs among pediatric patients’ studies recommend the use of rules based on age, and weight like Dilling’s rule and Clark’s rule respectively (Nir-Neuman et al., 2018).
Drugs to Handle with Extra Care
According to the FDA, most of the drugs for pediatric patients have not been tested in this age group. As such great caution needs to be taken when prescribing drugs with an increased risk of toxicity and severe side effects such as antidepressants (venlafaxine, paroxetine, fluoxetine, duloxetine, imipramine, and escitalopram), which have been reported to increase the risks of suicidality in children (Pratico et al., 2022).
Most drug labels lack information for use among children. As such, clinicians tend to use these drugs off-label especially when there is no alternative and studies have proven a great effectiveness of the medication. However great caution should be taken when prescribing drugs with high risks of toxicity and serious adverse effects.
De Zen, L., Marchetti, F., Barbi, E., & Benini, F. (2018). Off-label drugs use in pediatric palliative care. Italian Journal of Pediatrics, 44(1), 1-6. https://doi.org/10.1186/s13052-018-0584-8
Nir-Neuman, H., Abu-Kishk, I., Toledano, M., Heyman, E., Ziv-Baran, T., & Berkovitch, M. (2018). Unlicensed and off-label medication use in pediatric and neonatal intensive care units: no change over a decade. Advances in therapy, 35(7), 1122-1132. https://doi.org/10.1007/s12325-018-0732-y
Pratico, A. D., Longo, L., Mansueto, S., Gozzo, L., Barberi, I., Tiralongo, V., … & Drago, F. (2018). Off-label use of drugs and adverse drug reactions in pediatric units: a prospective, multicenter study. Current drug safety, 13(3), 200-207.
The patient suffers from community-acquired pneumonia. The Centers for Disease Control and Prevention (CDC) (2020) defines pneumonia as a disease that affects the lungs and causes mild to severe sickness in individuals of all ages. According to Prina et al. (2015), the most prominent symptoms of the disease include dyspnea, chest pain, and fever. These acute symptoms are depicted once there is a lower respiratory infection. Therefore, the patient requires an examination of his health needs, treatment plan, and education.
For the patient’s health needs, a complete assessment is required for patient HH to provide a timeline of when the occurrences and symptoms led to his hospitalization. A bedside finger stick and a set of crucial signs are required to proceed with the plan (Comerlato et al., 2020). Moreover, IV hydration, oxygen saturation monitoring, and proper nutrition are necessary for the patient. The cause of vomiting and nausea is unknown and needs to be resolved to prevent the chances of hypoglycemia and improve his dietary status.
Additionally, the patient must be on a spectrum antibiotic regime for treatment. Moreover, the doctors have to give Azithromycin and develop a plan for the causative agent, especially if the fungus or bacteria is unknown. HH also needs respiratory cultures and blood work to determine the source of the infection (Rosenthal & Burchum, 2021). The patient must be placed on three days of Ceftriaxone treatment as part of the treatment plan. HH requires nutrition and hydration therapy for dietary concerns and has to be continued until vomiting and nausea are reduced. The treatment is necessary to avoid resistance to antibiotics.
The patient needs to be educated on monitoring his oxygen level regularly and weaned off properly if he is not oxygen dependent at home. He will be made to understand the benefits of having a more active lifestyle, utilizing an incentive spirometer for lung expansion to hinder mucus seal and pneumonia reinfection. The patient will also need to be trained to monitor his blood pressure closely to maintain his baseline (Metlay et al., 2019). The patient dietary plan and medication agreement should be reviewed with the help of the patient to control hyperlipidemia sufficiently. It is essential that coaching and follow-up be provided consistently to ensure they are well conversant with HTN, HLD, and DM, putting him at frightening risk for stroke. The education program can be delivered face to face or online if the patient is at home. Face-to-face education is preferred due to its high effectiveness in enhancing the understanding of the patient.
Centers for Disease Control and Prevention. (2020). Pneumonia: An infection of the lungs.
Comerlato, P. H., Stefani, J., Viana, M. V., & Viana, L. V. (2020). Infectious complications associated with parenteral nutrition in intensive care unit and non-intensive care unit patients. Brazilian Journal of Infectious Diseases, 24(2), 137–143.
Metlay, J. P., Waterer, G. W., Long, A. C., Anzueto, A., Crothers, K., Cooley, L. A., Dean, C. N., Fine, M. J., Flanders, S. A., Griffin, M. R., Metersky, M. L., Musher, D. M., Restrepo, M. I. & Whitney, C. G. (2019). Diagnosis and treatment of adults with community-acquired pneumonia. An official clinical practice guideline of the American Thoracic Society and Infectious Diseases Society of America. American journal of respiratory and critical care medicine, 200(7), e45-e67.
Prina, E., Ranzani, O. T., & Torres, A. (2015). Community-acquired pneumonia. The Lancet, 386(9998), 1097-1108.
Rosenthal, L. D., & Burchum, J. R. (2021). Lehne’s pharmacotherapeutics for advanced practice nurses and physician assistants-E-book (2nd ed.) St. Louis, M.O: Elsevier Health Sciences.