The right to health is an inalienable right of every individual. Doctors are bound by the Hippocratic oath never to cause harm and promote the patient's best interest. When faced with a medical dilemma, doctors sometimes prescribe off-label drugs to children to safeguard their health. Off-label use is the prescription of approved drugs for an unapproved purpose. The Food and Drug Administration (FDA) is a federal oversight board charged with manufacturing, labeling, and advertisement of therapeutic drugs (Committee of Drugs, 2019). The FDA's approval might take a long time that the patient cannot afford, forcing the doctor to prescribe off-label use of a drug.
Secondly, a doctor will prescribe an off-label use drug if confident and with the informed consent of the patient's guardian that the efficacy levels are sufficient. Doctors are bound to do everything within their means to safeguard the patient's interest. Equally, doctors are required to disclose the benefits, risks, the right to a second opinion, and alternative options before undertaking any medical interventions. The disclosure enables the guardians to give informed consent (Furey & Wilkins, 2016). Expert opinion on using off-label use drugs such as antihistamines and antibiotics like azithromycin is also used during prescription.
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Whereas doctors enjoy the discretion of prescribing over-the-counter drugs, strategies must be adopted by FDA to make them safer. These strategies are to be affected by the FDA within its oversight mandates (Committee of Drugs, 2019). The FDA may request further studies on drugs such as azithromycin and lorazepam before authorizing. Abuse of antibiotics results in the development of resistance by the body, which is dangerous. The dosage of off-label drugs must be guided by medical judgment (Yackey et al., 2019). While the latter does not advise the FDA, they could add a warning to the drug label. They may also compulsorily withdraw the drugs from the market.
References
Furey, K., & Wilkins, K. (2016). Prescribing “Off-Label”: What Should a Physician Disclose? AMA Journal of Ethics, 18(6), 587-593. https://doi.org/10.1001/journalofethics.2016.18.6.ecas3-1606
Committee on Drugs, & MMM. (2014). Off-label use of drugs in children. Pediatrics , 133 (3), 563-567. https://doi.org/10.1542/peds.2013-4060
Yackey, K., Stukus, K., Cohen, D., Kline, D., Zhao, S., & Stanley, R. (2019, March 3). Off-label Medication Prescribing Patterns in Pediatrics: An Update . Hospital Pediatrics , 9 (3), 186-193. https://doi.org/10.1542/hpeds.2018-0168
