Nursing – off label dosing for pediatrics

Nursing – off label dosing for pediatrics


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.

When treating children, prescribers often adjust dosages approved for adults to accommodate a child’s weight. However, children are not just “smaller” adults. Adults and children process and respond to drugs differently in their absorption, distribution, metabolism, and excretion.

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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.

To Prepare

  • Review the interactive media piece in this week’s Resources and reflect on the types of drugs used to treat pediatric patients with mood disorders.
  • Reflect on situations in which children should be prescribed drugs for off-label use.
  • Think about strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence. Consider specific off-label drugs that you think require extra care and attention when used in pediatrics.

By Day 5 of Week 11

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.

Reminder: The College of Nursing requires that all papers submitted include a title page, introduction, summary, and references.






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

Prescription of off-label medication in pediatrics is common due to the lack of specific data regarding efficacy, dosing, and safety of medications prescribed to children. One circumstance that children are prescribed off-label drugs is when there is no specific governmental approval or drug information for on-label pediatric prescribing (Allen et al., 2018). This leads to the clinician prescribing the medicine off-label. For example, enalapril has an FDA-approved indication for treating heart failure and hypertension in adults but has an FDA-approved indication for hypertension only in children. It is, however, commonly used by clinicians to treat heart failure in children. Other circumstances include lack of standard treatment, lack of clinical trials, and shortage of alternative therapy for the children. Examples include the use of antidepressants to treat attention deficit hyperactive disorder.

Describe Strategies to Make the Off-Label Use and Dosage of Drugs Safer for Children from Infancy to Adolescence

To increase the safety of an off-label prescription, the clinician should be well informed about the drug. According to Mei et al. (2019), the clinician should perform a thorough investigation that takes into consideration possible side effects of the drug and risks involved. In other countries like China, strategies formulated to increase safety include monitoring adverse drug reactions, obtaining approval from the pharmacy administration committee, requesting the off-label drug based on supporting evidence and establishing a database for the off-label drugs, and making regular updates. Another strategy is obtaining informed consent, although the strategy may not apply to medication supported by scientific evidence. The Institute of Medicine, in collaboration with drug regulatory agencies, envisions a post-market surveillance system that enhances documentation of prescribed drugs and their indications, including the off-label prescription (Eguale et al., 2016). Examples of off-label drugs that require extra care and attention in pediatrics include Aspirin, which may lead to severe liver and brain problems. Another example is Tetracycline, a commonly prescribed antibiotic that may damage the teeth of children below eight years.




Allen, H. C., Garbe, M. C., Lees, J., Aziz, N., Chaaban, H., Miller, J. L., … & 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.

Eguale, T., Buckeridge, D. L., Verma, A., Winslade, N. E., Benedetti, A., Hanley, J. A., & Tamblyn, R. (2016). Association of Off-Label Drug Use and Adverse Drug Events in An Adult Population. JAMA Internal Medicine176(1), 55-63.

Mei, M., Xu, H., Wang, L., Huang, G., Gui, Y., & Zhang, X. (2019). Current Practice and Awareness of Pediatric Off-Label Drug Use in Shanghai, China-A Questionnaire-Based Study. BMC Pediatrics19(1), 1-7.