Case study : Circumstances under which Children should be Prescribed Drugs for off-label Use

Case study


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.


Circumstances under which Children should be Prescribed Drugs for off-label Use

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There are major reasons children are prescribed off-label medicines include the lack of approved, normal, and safe treatment alternatives for a particular disorder or illness. Another reason is inadequate pediatric knowledge in Summary of Product Characteristics (SmPC) which raises a public health concern today (Allen et al., 2018). Off-label medications function differently in different patients or individuals because they have varied needs (Allen et al., 2018). Therefore, healthcare providers should carefully study the medications and make an informed clinical decision to prescribe the medicine. Other reasons that may necessitate off-label drug use are failure of standard treatment, shortage of alternative types of therapy for specific age groups, and lack of or inadequate clinical trials in special age groups that define the dosage, efficacy, and safety of medications. These age groups include elderly persons, pregnant women, and babies or newborns.

There are other circumstances whereby children might be prescribed off-label medications, such as during emergencies (Tefera et al., 2017). Suppose a child is involved in an accident that requires medical attention to save their life. In that case, the medical provider might give the child an off-label medicine to help ease pain and stabilize them while awaiting further medical care. Moreover, a medical provider can decide to prescribe off-label drugs to a child if there is enough persuasive evidence of the drug’s usefulness and safety in complicated situations. An example is when a chemotherapy drug is used to treat one type of cancer, and the provider decides to use it for treating a different type of cancer.

Question 2

The healthcare sector must promote the use of medication by creating drugs that are appropriate for children in regard to dosage, strength, and flavor to avoid the pervasive and increased use of off-label drugs. Most off-label drugs used by healthcare providers lack substantive scientific support on the treatment of the conditions they are prescribed for (Tefera et al., 2017). The strategies that can make off-label use safer include more detailed SmPC on drugs. Medicine producers should ensure that the medications are tested for efficacy, tentative signs of effectiveness in adults, and pharmacokinetics before being prescribed to infants and children (Pratico et al., 2018). More research into the use of off-label drugs by children will improve health outcomes in children by promoting the availability and production of medicine and drugs effective for children. Moreover, research will help ensure these medications are ethically researched, high quality, and properly approved. This will avail more drug information for children use.

Moreover, the use of off-label does not imply that the drugs used are dangerous. There is an increased use of off-label medications today, and this requires guardians and parents to ascertain the information of these drugs before allowing their children to use them. Medical providers should explain the negative and positive effects of the medicine and allow the parents to make informed decisions based on this information (Pratico et al., 2018). Most healthcare professionals use off-label medications such as antidepressants, antihistamines, and antibiotics to treat children as there are no alternatives (Allen et al., 2018). For instance, medical practitioners have used antihistamines to treat respiratory infections in children. Some off-label drugs that require extra attention and care when being used in children are chronic disease drugs like cancer drugs and antidepressants (Allen et al., 2018). Examples include morphine for pain in infants and high dose Amoxicillin (Allen et al., 2018). To make these medications safer for use, proper dosage measures through detailed SmPC labeling should be employed to avoid assumptions on the right and most effective dosages for children at any age.




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.

Pratico, A. D., Longo, L., Mansueto, S., Gozzo, L., Barberi, I., Tiralongo, V., … & Drago, F. (2018). Off-label use of drugs and adverse drug reactions in pediatric units: a prospective, multicenter study. Current drug safety13(3), 200-207.

Tefera, Y. G., Gebresillassie, B. M., Mekuria, A. B., Abebe, T. B., Erku, D. A., Seid, N., & Beshir, H. B. (2017). Off‐label drug use in hospitalized children: a prospective observational study at Gondar University Referral Hospital, Northwestern Ethiopia. Pharmacology research & perspectives5(2), e00304.