Use of off label drugs in the pediatrics group is a controversial issue. Most practitioners fear drugs off label for the fear of the litigations that might arise in case of adverse drug reactions which might lead to them being sued for negligent prescribing (Mei et al., 2019). To avoid such cases, it is important that the practioners exercises caution before engaging in off-label prescription. Practioners should only prescribe drugs off label where there exists sufficient evidence that the drug is effective in treating a condition despite the specific use not being included in the labelling of the drug by FDA ("Off-label use of drugs in children," 2014). The practioners should also have prescribed other available options which have been approved for the treatment of the particular condition without success leaving him with the only option of going for off label prescription. In such circumstances, the practitioner must discuss with the parent of the child being treated regarding the off-label status of the drug and that there is a potential for undesired effects (Boston Children's Hospital, n.d.) . The decision-making process must be documented in the patients file and informed consent obtained to prevent instances of litigation for negligent prescription. It is important that the practioners monitors the progress of the patient closely after prescription to ensure that adverse events are discovered in time and appropriate measures taken.
Various measures can be used to make the use of off label drugs safer for children. The first strategy is by basing the use based on evidence (Wu & Wu, 2014) . This evidence might be based on expert opinion for the group that they are dealing with or they can rely on the evidence of the efficacy of the drug from other populations such as adult populations who have been treated successfully with a drug. Health Committees should also be formed to assess the effectiveness of using certain off label drugs in the treatment of specific disorders (Dresser & Frader, 2009) . Some off label drugs such as antidepressants for example Prozac as well as antipsychotic medications require extra care while being used in children because of the potential to cause severe side effects.
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References
Boston Children's Hospital. (n.d.). What to consider when considering "off-label" drug prescriptions for children . https://www.childrenshospital.org/centers-and-services/departments/general-pediatrics/clinician-resources/off-label-drug-prescriptions
Dresser, R., & Frader, J. (2009). Off-label prescribing: A call for heightened professional and government oversight. Journal of Law, Medicine & Ethics , 37 (3), 476-486. https://doi.org/10.1111/j.1748-720x.2009.00408.x
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. BMC Pediatrics , 19 (1). https://doi.org/10.1186/s12887-019-1664-7
Off-label use of drugs in children. (2014). Pediatrics , 133 (3), 563-567. https://doi.org/10.1542/peds.2013-4060
Wu, H., & Wu, G. (2014). Strategy to address innovative off-label medication use in China: Grading management. European Journal of Clinical Pharmacology , 70 (10), 1271-1273. https://doi.org/10.1007/s00228-014-1729-3
