Off Label Drug Use in Pediatrics

Circumstances under which children should be prescribed drugs for off-label use are when the medication they need is not available in a dosage distributed for children but has been shown to be used safely by children when given in the appropriate dosage level based on their body weight in the past. Care providers should be aware of what medications can be safely given to children in this way and what precedents have been established in the past. Just as in law, a court will examine prior cases to see how they have been judged before a decision is made on a current case, a nurse should reflect on what medications have been safely prescribed to children using off-label drugs and should only prescribe those that have been used safely before.
If the nurse feels compelled to prescribe a medication that has no precedent with use among children, the nurse should exercise restraint before embarking on this course because he or she does not want to be the one to set the precedent that such a drug is actually not safe for children to process because of the lack of development in their bodies so far. The safest course of action is to follow custom and tradition that is time honored and proved safe and effective over so many years. Since there are too few scientific studies that can help to verify all of what is needed for children’s health, professionals themselves have to keep tabs on what is used, what is effective, what has not been used, and so on.
In a worst case scenario, a nurse should consult with another professional to get a second opinion and should never attempt to make a judgment call alone, especially if there is uncertainty. As Gausvik, Lautar, Miller, Pallerla and Schlaudecker (2015) note, communication among nurses is vital to improving the quality of care of patients and interdisciplinary communication can be especially effective in helping nurses to make the right decision about what to prescribe for a child patient because someone else from another discipline, such as a physician, could give insight that the nurse does not have, and help to determine whether a drug would be safe to prescribe. A nurse should never be afraid to ask for assistance and for professional advice on such matters, especially as Gausvik et al. (2015) show that this type of behavior is laudable and to be recommended in health care.
To make the dosage safe for children, infancy to adolescence, the protocol promoted by Neville et al. (2014) could be used. Their recommendation is that the care provider who writes the prescription for the drug has to determine what drug to prescribe and whether it is suitable for the child based on journal publications, available research and evidence and other information that is available for the off-label drug. Medical judgment is extremely important in these cases and the care provider should base all decisions on evidence available.
Some off label drugs that are used for children but still require special care and consideration are: morphine which has been used to address pain issues in children under the age of 13 but should not be given casually; salbutamol which has been used every two hours for some children; and rifampicin, which has been used for enzyme induction in infants suffering from biliary atresia (Mir & Geer, 2016). These drugs should be considered carefully before being given in any dosage to children and the strategy to do so is to be aware of the child’s medical history, to note allergies, and to monitor the child for possible side effects that could compromise the child’s health. The drugs should also be carefully administered and dosages rigidly adhered to.
References
Gausvik, C., Lautar, A., Miller, L., Pallerla, H., & Schlaudecker, J. (2015). Structured
nursing communication on interdisciplinary acute care teams improves perceptions of safety, efficiency, understanding of care plan and teamwork as well as job satisfaction. Journal of Multidisciplinary Healthcare, 8, 33.
Mir, A. N., & Geer, M. I. (2016). Off-label use of medicines in children. Int J Pharm Sci
Res, 7(5), 1820-28.
Neville, K. A., Frattarelli, D. A., Galinkin, J. L., Green, T. P., Johnson, T. D., Paul, I. M.,
& Van Den Anker, J. N. (2014). Off-label use of drugs in children. Pediatrics, 133(3), 563-567.