A healthcare practitioner can administer an off-label prescription when they cannot access a labeled medicine or when the labeled dosage is not appropriate for children. For instance, most pediatric medicines have not been tested for the appropriate age, and their dosages have been retrieved from adults and older children (Schrier et al., 2020). Besides, a healthcare practitioner may prescribe age-appropriate off-label to minimize administration errors. Clozabam is one of the off-label medicines that pediatrics administer to children with Dravet syndrome (Schrier et al., 2020). Also, some countries may allow the use of given medicines in children. For instance, midazolam oral suspension is licensed in Germany but illegal in Belgium (Schrier et al., 2020). In other instances, the licensed medicine may not be appropriate to children due to harmful effects; hence, off-label medicine may be an alternative. Healthcare practitioners can also prescribe off-label medicines to children if the medical community has not updated the product summaries despite the available evidence (Schrier et al., 2020). This approach enables physicians to use the existing medicines creatively when evidence of their effectiveness exists, but the federal licensing for children has not occurred.
Healthcare professionals have implemented measures to ensure off-label medicines are safe for children. For example, they rely on current evidence when requesting off-label drug use (Mei et al., 2019). Before administering off-label medicines, the ethics committee and pharmacy administration committee must approve their use. Also, healthcare professionals must obtain consent from the parents and explain to the parents the off-label drugs’ risks and benefits and receiving their approval in return. Besides, healthcare practitioners monitor any adverse drug reactions (Mei et al., 2019). They check the patients regularly to determine to stop or continue the dosage. The physicians also update the off-label medicines’ database. However, healthcare professionals should practice extra care when using citalopram and trazodone to treat manic-depressive psychosis and anxiety, respectively (Vijay et al., 2018). There is insufficient evidence supporting the use of these off-label drugs. Aripiprazole used to treat depressive disorder, also requires extra care (Vijay et al., 2018). There is insignificant evidence supporting the effectiveness of off-label medication when treating depression.
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References
Mei, M., Xu, H., Wang, L., Huang, G., Gui, Y., & Zhang, X. (2019). Current practice and awareness of pediatric off-label drug use in Shanghai, China –A questionnaire-based study. BioMed Central Pediatrics , 19 (281). https://doi.org/10.1186/s12887-019-1664-7
Schrier, L., Hadjipanayis, A., Stiris, T., Ross-Russell, R. I., Valiulis, A., Turner, M. A., van den Anker, J., et al. (2020). Off-label use of medicines in neonates, infants, children, and adolescents: a joint policy statement by the European Academy of Pediatrics and the European Society for Developmental Perinatal and Pediatric Pharmacology. European Journal of Pediatrics , 179 (5), 839-847. https://doi.org/10.1007/s00431-019-03556-9
Vijay, A., Becker, J. E., & Ross, J. S. (2018). Patterns and predictors of off-label prescription of psychiatric drugs. Public Library of Science One , 13 (7), e0198363. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0198363
