Off-Label Drug Prescription

Subject: Pediatrics
Pages: 1
Words: 381
Reading time:
2 min

Children may require off-label drug prescription depending on specialty concerns, level of care available, and patient characteristics. Pratico (2018) defines off-label drug prescription as “any usage of approved drugs outside the approved marketing authorization” (p. 200). The unlicensed use of off-label prescription often occurs in medical and surgical wards and with critically ill children (Tefera et al., 2017). A review of literature by Mir and Geer (2016) found non-availability or absence of a standard, licensed, effective, and safe therapeutic options as the leading cause for off label prescription among children. Other reasons are the lack of alternative therapy for neonates and infants, prohibitive costs of conventional drugs, faster availability of FDA unapproved drugs, and better patient care using off-label drugs. Although off-label prescription can deliver an excellent therapeutic effect, medicines such as Amoxicillin, Atenolol, and Sildenafil are highly prescribed off-label and can be lethal for neonates and infants and fail to achieve the intended results.

Common off-label prescriptions include Amoxicillin used for Otitis media in children, Atenolol for hypertension, and Sildenafil for pulmonary hypertension. Mir and Geer (2016) also cite Intranasal Desmopressin, Morphine, and Salbutamol among leading off-label prescription drugs for children globally. In addition to Rifampicin, Tobramycin, and Cyclizine, off-label drugs can be fatal and result in ADR and adverse reactions (Mirr and Geer, 2016). However, following the guidelines on the safe administration of medications by the World Health Organization, Promoting Safety of Medicines for Children, children can be protected from risks of off-label prescriptions (World Health Organization [WHO], 2007). Besides, regulators should enforce the Pharmaceuticals for Children Act (BPCA) and the Paediatric Research Equity Act, 2003(PREA), requiring practitioners to use regulated drugs only. Particular care should be given when administering medications containing benzyl alcohol, which is toxic in dosages in 99-234mg/kg/day (Akinmboni et al., 2018). Adherence to the safety measures established by internal hospital systems, state and federal regulators can prevent risks to infants and neonates from off label prescriptions.

Many reasons, including the lack of access to conventional drugs, medical emergencies, and the high cost of medication, influence off-label prescriptions. Common types of such medicines include Amoxicillin, Atenolol, and Sildenafil. Failure to adhere to guidelines by the WHO and other institutions continues to expose infants and neonates to risk, as the world experiences a rise in off-label prescriptions.


Akinmboni, T. O., Davis, N. L., Falck, A. J., Bearer, C. F., & Mooney, S. M. (2018). Excipient exposure in very low birth weight preterm neonates. Journal of Perinatology, 38(2), 169-174. Web.

Mir, A. N., & Geer, M. I. (2016). Off-label use of medicines in children. International Journal of Pharmaceutical Sciences and Research, 7(5), 1820. Web.

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 Safety, 13(3), 200-207. Web.

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 & Perspectives, 5(2), e00304. Web.

World Health Organization. (2007). Promoting safety of medicines for children. Web.