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[SOLVED] Explain the circumstances under which children should be prescribed drugs for off-label use

Explain the circumstances under which children should be prescribed drugs for off-label use

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.

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.

Expert Answer and Explanation

Off-Label Drug Use in Pediatrics

Off-label refers to the utilization of drugs that are not included in the approved labeling package of that specific drug (Frattarelli et al., 2014). The main reason for using off-label is solely for the benefit of a patient in the event that existing labeled drugs are inefficient. Be that as it may, off-label is not an implication to an illegal, improper, investigational, or contraindicate the use of a drug; rather, it is a legal, operational drug that is pending approval by the FDA (Gore et al., 2017). There are various circumstances within which children should be prescribed with off-label drug use.

Circumstances to Allows Off-Label use in Children

According to the American Academy of Pediatrics (AAP) (2014), there are less than half of existing medication that provides specific labeling for young children and infants. This implies that a pediatrician has to make decisions based on their intuition and clinical judgment on the appropriate prescription dosage (Yackey et al., 2019). Accordingly, the main circumstance that a pediatrician has to offer off-label drug prescription is because there is an overwhelming number of critically essential medications that do not have labeling information regarding their usage in children (American Academy of Pediatrics, 2014). This is a major concern mainly due to the different yet special populations of children ranging from children with rare or chronic diseases, preterm infants, and newborns.

The absence of required labeling of drugs to be used with a specific age illness or age set is not an inference that the overall use of the drug if flawed or improper to the children. In retrospect, it only indicates that the FDA is yet to approve the present evidence required by law that allows the inclusion of the label to the drug (Gore et al., 2017). A pediatrician is allowed to make decisions based on expert opinion, and the lack of labeling in specific drugs does not signify that therapy cannot be supported on collected data or professional experiences. In contrast, the lack of labeling only means that the manufacturer or supplier of the drug has to submit evidence to the FDA for approval.

Making Off-Label Drugs Safer

There are various strategies that are put in place to make the off-label use and dosage of drugs safer for children uptake from infancy up to their adolescent stages (Yackey et al., 2019). To make up for the lack of labels, some drugs indicate on their packages that the drug is yet to meet the required tests and approvals to ascertain the safety and efficacy in pediatric patients (Frattarelli et al., 2014). Other drugs provide explicit and vivid evidence-based warnings, including any contradictions where the label is indicated. It is the mandate of the pediatrician to comprehend the distinction between the contradictions or explicit warning against the use of the drug versus the lack of labeling or FDA approval for a specific dosing regimen or use (Gore et al., 2017). As such, the understanding of the information relating to pediatric use is essential and a form of best practice for making therapeutic decisions.

In conclusion, there is a need to understand that the FDA does not in any way regulates the utilization of drugs as pertains to medical practice. Pediatricians can recommend the prescription of off-label use drugs to children patients based on their expert opinion. The absence of labels does not signify the improper or illegal use of medication, rather insufficient evidence required by law to authenticate or approve the use of medication in children. However, pediatricians should only make use of off-label drugs only on the circumstance that the existing label drugs are not effective in providing the required output.


American Academy of Pediatrics. (2014). AAP Makes Recommendations On Use of Off-Label Drugs for Children. Retrieved 20 April 2020, from

Frattarelli, D. A., Galinkin, J. L., Green, T. P., Johnson, T. D., Neville, K. A., Paul, I. M., & Van, J. D. A. (2014). Off-label use of drugs in children. Pediatrics133(3), 563-567.

Gore, R., K Chugh, P., D Tripathi, C., Lhamo, Y., & Gautam, S. (2017). Pediatric off-label and unlicensed drug use and its implications. Current clinical pharmacology12(1), 18-25.

Yackey, K., Stukus, K., Cohen, D., Kline, D., Zhao, S., & Stanley, R. (2019). Off-label medication prescribing patterns in pediatrics: an update. Hospital pediatrics9(3), 186-193.

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