Off-label drug prescriptions mean prescribing medication that has been tested and approved for use but for treatment of the conditions different from those that were indicated by the manufacturer. Children should be prescribed drugs for off-label use with caution and when considering that medication can have a varying effect on their bodies. This paper will present a narrative that explains in what cases children can be prescribed drugs off label.
Biologically, the bodies of children and adolescents still develop, and the effect of medication on them may be unpredictable. Panther et al. (2017) argue that “prescribing decisions be made on the basis of product labeling, clinical evidence, expert judgment, and published literature” (p. 423). Professionals should be aware of how the medication is approved and labeled in the United States to make prescription decisions. The FDA labels medication and recommendations for the use for certain age groups based on the clinical trials and empirical evidence (Panther et al., 2017). Hence, if a certain medication were not tested on the population of children, the FDA would not put this population on the label, which makes such prescription “off label.” For example, a three years old child with ADHD would be recommended treatment of therapy. However, many professionals also prescribe alpha-agonists off-label (Panther et al., 2017).
Strategies to make off-label drugs safer for children include governmental initiatives for better control and more clinical trials to study the effect of medication on children (Corny et al., 2017). Professionals should be cautious of medications such as aspirin and salicylates (Rosenthal & Burchum, 2021). In summary, off-label drug prescriptions are common in the United States. However, this practice should be used with extreme caution as the effect of medication on children may vary. Professionals should use their judgment and evidence to make these decisions.
Corny, J., Lebel, D., Bailey, B., & Bussières, J. (2015). Unlicensed and off-label drug use in children before and after pediatric governmental initiatives. The Journal of Pediatric Pharmacology and Therapeutics, 20(4), 316-328. Web.
Panther, S., Knotts, A., Odom-Maryon, T., Daratha, K., Woo, T., & Klein, T. (2017). Off-label prescribing trends for ADHD medications in very young children. The Journal of Pediatric Pharmacology and Therapeutics, 22(6), 423-429. Web.
Rosenthal, L. D., & Burchum, J. R. (2021). Lehne’s pharmacotherapeutics for advanced practice nurses and physician assistants (2nd ed.) Elsevier.