Posted: February 19th, 2022

Off-Label Drugs for Children

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Off-Label Drugs for Children
Many drugs used by children and adolescents have either not been licensed or are being used contrary to the license. However, most healthcare experts can authorize administration to children, medication licensed for an adult (Corny et al.). Off-label prescription, therefore, plays a major role in ensuring that individual patients, mainly children and adolescents, acquire the medication needed to ensure their health. However, this practice should be done with great precaution to avoid the related side effects.
A huge number of drugs with no labeling information for use in pediatrics is one of the reasons off-label prescription is done. Practitioners use their professional judgement to determine these uses (“Off-Label Use of Drugs in Children”). Other circumstances that necessitate off-label prescription include surgical procedures for children, acuteness of a disease and in-hospital deaths. Under these adverse conditions, off-label prescription is given to control pain, facilitate a medical procedure or even cure an illness. Autonomic nervous system agents, fluids, nutrients and gastrointestinal tract agents are examples of antibiotics commonly administered off-label (Shah SS).
Adverse drug reactions for children may occur if a mistake is made during off-label prescription and administering of drugs such as methylphenidate, adrenergic nose drops and dimenhydrinate. Mechanisms such as use of bar codes for drug identification, packaging and labelling of single doses and automation of the patient’s data entry systems can help prevent such errors (Wimmer et al.). Other considerations made while prescribing off-label drugs for children include; existing evidence of successful administration of medication for a particular disease previously, proper research on drugs to be used by children and correct decision of a doctor grounded on an expert opinion. Regulation of insurance companies should also be done to prevent companies taking advantage of lack labeling information for their advantage at the expense of a child’s health. These strategies, therefore, play an important role in curbing any adversity that might arise.

Works Cited
Corny, Jennifer et al. “Unlicensed and Off-Label Drug Use in Children Before and After Pediatric Governmental Initiatives”. The Journal of Pediatric Governmental Initiatives, vol. 4, no. 20, 2015, pp. 316-328. Accessed 9 Feb 2020.
“Off-Label Use of Drugs in Children”. vol.133, no. 3, 2014, pp. 563-567. American Academy of Pediatrics (AAP), doi:10.1542/peds.2013-4060.
Shah SS, et al. “Off-Label Drug Use in Hospitalized Children. – Pubmed – NCBI”. Ncbi.Nlm.Nih.Gov, 2007, https://www.ncbi.nlm.nih.gov/pubmed/17339510. Accessed 9 Feb 2020.
Wimmer, Stefan et al. “The Safety of Drug Therapy in Children”. Deutsches Arzteblatt International, vol. 112, no. 46, 2015, pp. 781-787. Accessed 9 Feb 2020.

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