WK 11 Assignment: Off-Label Drug Use in Pediatrics The unapproved use of approved drugs, also called off-label use, with children is quite common. This is because pediatric dosage guidelines are typically unavailable since very few drugs have been specifically researched and tested with children.

Off-Label Drug Use in Pediatrics

Using off-label drugs in pediatrics is related to the lack of pediatric-specific pharmacological and pharmacokinetic data to guide decisions on drug efficacy, dosage, and safe use of medications in children (Allen et al., 2018). Due to the lack of this data, the FDA has no standard based on the approval of medication for pediatric care. There are various circumstances in which pediatricians are forced to prescribe off-label medications to children. For example, in a case where the child has allergies to FDA-approved medications for children, the doctor will be forced to prescribe an off-label alternative. A doctor will also have to prescribe an off-label drug if, based on their professional judgment, the FDA-approved drug will cause an interaction with other currently prescribed drugs. A child may also be prescribed off-label drugs if a physician knows that the alternative medication has higher efficacy than the approved ones.

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With the lack of clinical trials and dosage evidence of major medications in children and infants, the issue of the effectiveness and therapeutic safety of off-label drugs persists in pediatrics (Lee et al., 2018). However, the use of off-label medications in pediatrics can be made by creating awareness among physicians by developing a national guideline (Mei et al., 2019). The enforcement of legislation to guide drug development can facilitate drug children-focused drug research, improving drug information availability and industry accountability (Gore et al., 2017). A continuous review of off-label medications in pediatrics can help improve physicians’ understanding of the drugs and make professional decisions based on risk/benefit during prescription. Some commonly prescribed off-label medications that require care and attention include ceftriaxone, sold as Rocephin; cloxacillin, usually sold as Cloxapen; and gentamycin, sold as Cidomycin, Genticyn, and Garamycin. These medications are prescribed off-label in the treatment of bacterial infections.

References

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 Association, 111(8), 776. /pmc/articles/PMC6677268?