NURS 6521 Assignment: Off-Label Drug Use in Pediatrics

Off-Label Drug Use In Pediatrics Sample Paper 1

Major depressive disorder is a significant pediatric and adolescent health problem associated with significant morbidity. These patients suffer from impaired social functioning, school difficulties and have an increased risk of physical illness and substance abuse. It is also associated with an increased risk of mortality by suicide. Treatment should therefore be initiated with both psychotherapy and pharmacotherapy.

Choosing of antidepressant is however a challenge for pediatric patients. This is because of the smaller evidence available for antidepressant efficacy compared to adult patients. Selective serotonin reuptake inhibitors (SSRIs) are the first line antidepressants in both pediatric and adult patients with only a few of these antidepressants FDA approved to be used in pediatrics. The lack of FDA approval for pediatric patients is mostly attributed to the lack of sufficient testing. This means that some antidepressants used in pediatrics are prescribed off—label. Use of off-label drugs is common in pediatrics. Off label drugs use is when drugs are used for treatment of conditions different from the ones they were originally intended for (Gore et al., 2017).

Off-label drug use is recommended in children if they do not receive adequate improvement after using first line drugs (Dwyer & Bloch, 2019). In patients with depressive disorders, improvements can be seen when switching form one SSRI to another e.g., when a switch from Prozac to Zoloft is made (Boyce et al., 2020).

However, certain considerations need to be made when drugs are used off label. These include the child’s body weight and stage of development. This is relevant because these factors can affect how the child will tolerate the drug (Collier et al.,2017). Metabolism is also affected by these factors and consequently the amount of drugs prescribed. Another important consideration is the side effects associated with the drugs. SSRIs, for example, are more likely to cause suicidal ideations in pediatric and adolescent patients than in adults.


Boyce, P., Hopwood, M., Morris, G., Hamilton, A., Bassett, D., Baune, B. T., Mulder, R., Porter, R., Parker, G., Singh, A. B., Outhred, T., Das, P., & Malhi, G. S. (2020). Switching antidepressants in the treatment of major depression: When, how and what to switch to?. Journal of Affective Disorders261, 160–163.

Collier, H., Nasim, M., & Gandhi, A. (2017). Prescribing in obese children: how good are paediatricians?. Archives Of Disease In Childhood102(1), 61–62.

Dwyer, J. B., & Bloch, M. H. (2019). Antidepressants for Pediatric Patients. Current Psychiatry18(9), 26–42F.

Gore, R., Chugh, P. K., Tripathi, C. D., Lhamo, Y., & Gautam, S. (2017). Pediatric Off-Label and Unlicensed Drug Use and Its Implications. Current Clinical Pharmacology12(1), 18–25.

Off-Label Drug Use in Pediatrics Sample Paper 2

The use of an approved drugs for unapproved purposes is referred to as off-label use. The U.S. Food and Drug Administration (FDA), an organization in charge of the approval of medication use in the USA, regulates the use and applications of medications. The off-label use of medications is legal and common practice in the United States. This practice is risky in pediatric management because there is limited evidence-based data on the efficacy and safety of certain medications in the pediatric population (Allen et al., 2018). Various research studies have been done by pharmaceutical companies and the department of health to fill the knowledge gap in the past three decades.

Circumstances Under Which Children Should be Prescribed Drugs for Off-Label Use

Off-label prescription happens in the management of pediatrics for various reasons. When a standard, safe, and efficacious therapeutic agent for a particular condition is unavailable, an off-label prescription may be allowed. In pediatrics, this is common with the use of most antibiotic medications. The use of ceftriaxone has been used for most febrile conditions for which its use is not approved by the FDA. The use of sildenafil for pulmonary hypertension in infants is another example of off-label use of medications (Kelly et al., 2017). In other circumstances off-label prescription in children occurs when the clinical trials in the specific age groups are not available, the standard therapy fails, and when the alternative forms have shown more efficacy and effectiveness than the standard therapy in treating the same condition.

Strategies to Make the off-label Use and Dosage of Drugs Safer

Occasionally, clinicians may carry out off-label prescriptions because the approval process by the FDA takes longer or is quite expensive for a particular medication for which evidence-based trials and studies have shown substantial efficacy. The best strategy to promote medication safety in children can be achieved through improving the process of approval and clinical trials of such medications (Mir & Geer, n.d.). This mainly applies to chemotherapeutic agents. Various neoplastic conditions common in childhood can also occur in adults. In such cases, the same agents used to manage adults are used in children because there is no approved medication in children (Gore et al., 2017). Pharmacists and physicians should regularly monitor and report adverse reactions in children on off-label prescriptions. Approving the clinical trials of medications in children and neonates makes the overall process of approval faster and efficient.


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 Association111(8), 776–783.

Gore, R., Chugh, P. K., Tripathi, C. D., Lhamo, Y., & Gautam, S. (2017). Pediatric off-label and unlicensed drug use and its implications. Current Clinical Pharmacology12(1), 18–25.

Kelly, L. E., Ohlsson, A., & Shah, P. S. (2017). Sildenafil for pulmonary hypertension in neonates. Cochrane Database of Systematic Reviews8, CD005494. Mir, A. N., & Geer, M. I. (n.d.). Off-label use of medicines in children. International Journal Of Pharmaceutical Sciences And Research. Retrieved February 10, 2021, from