Off-Label Use of Drugs Discussion

Off-Label Use of Drugs Discussion

In the United States, the use of off-label drugs among children, infants and adolescents is of public health significance since most drugs do not have details and are not yet labeled for use in pediatrics. Off-label prescribing happens when a medication that has not been approved by the FDA is administered based on a specific child’s diagnosis or age. Off label medications should only be prescribed for children if the benefits of a drug outweigh the risks that a child is likely to experience (American Academy of Pediatrics, 2014). Off-label medications are commonly prescribed in the pediatric population since very few drugs have been tested and approved for use in children. Off-label prescribing should however only be encouraged in primary care settings and hospitals. Off-Label Use of Drugs Discussion


            According to Arcangelo et al., (2017), some of the best strategies that can be used to make off-label use and drug dosing safer for the pediatric population is emphasizing on more evidence based research about particular drugs which are used off-label. The results from all clinical trials of these researchers should be well published and availed including any negative studies. This is in accordance with the Best Pharmaceuticals for Children Act of 2002 which encourages pharmaceutical industries to perform and submit clinical trials on off-label medications used in the pediatric population. Due to limited research, in clinical practice, providers can rely on scholarly sources, the policy statements and practice guidelines provided by the AAP to prescribe off-label medications in the pediatric population (American Academy of Pediatrics, 2014). Off-Label Use of Drugs Discussion

An off-label medication which needs additional care and attention is immediate release amoxicillin for the management of mild, moderate or severe sinusitis among infants aged three months or younger. According to Tefera et al., (2017), it needs extra attention due to its likelihood to lead to adverse drug reactions and make an infant develop resistance.


American Academy of Pediatric Policy Statement. (2014). Off-Label Use of Drugs in Children. AAP News and Journals, 133(3), 563-567.

Arcangelo, V. P., Peterson, A. M., Wilbur, V., & Reinhold, J. A. (Eds.). (2017). Pharmacotherapeutics for advanced practice: A practical approach (4th ed.). Ambler, PA: Lippincott Williams & Wilkins.

Tefera, Y. G., Gebressillassie, B. M., Mekuria, A. B., Abebe, T. B., Erku, D. B., 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 and Perspectives, 5(2) Off-Label Use of Drugs Discussion


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