The Ethics Behind Assessment
Off-label drugs refer to those medications that healthcare providers prescribe and use without engaging these drugs’ licensed indications concerning age, dosage, route, and indication (Yackey et al., 2019). The off-label drugs prerequisite in children must be due to unmet medical needs. Hence, once the pediatrician decides to use off-label medication, they have to intervene in a medical condition whose licensed drugs are unavailable or when the presently licensed drugs may not be suitable or suboptimal (Pratico et al., 2018). For instance, in Adhya’s case, despite being a 17-year-old patient, she has to undergo a bone mallow transplant due to her leukemia condition, which is recommended for over 18-year-old patients (Mascolo et al., 2020).
The best strategy healthcare providers should engage in includes evidence-based trials to help improve the drug safety of children using off-label drugs (Rusz et al., 2021). That means there should be more financial incentives for these trials to aid in identifying the appropriateness of these drugs. Also, healthcare providers must ensure that they report any adverse effects of these drugs as required by their professional code. The healthcare providers in Adhya’s case have already discussed with the parents the need to carry out a bone marrow transplant and infertility as the main side effect (Mascolo et al., 2020). Since the healthcare providers are bound by the bioethics principles of beneficence, nonmaleficence, autonomy, and justice, it is essential to engage the hospital ethical committee to make informed decisions.
However, pediatricians need to ensure that off-label drugs like chemotherapy which, despite being approved to treat specific cancer, may also be effective in treating other cancers. For children, chemotherapy drugs must be administered carefully since they may result in infertility, growth problems, and delayed cognitive development (Brancati et al., 2021). Also, a bone marrow transplant needs to be assessed since it involves exposing the child to higher chemotherapy doses that may adversely affect the children or adolescents, like heart and kidney issues. In conclusion, when treating Adhya, options like immunotherapy will be essential since, instead of destroying body cells, it boosts one’s immune system, thus resulting in fewer side effects than a bone marrow transplant.
Brancati, S., Gozzo, L., Longo, L., Vitale, D. C., Russo, G., & Drago, F. (2021). Fertility preservation in female pediatric patients with cancer: a clinical and regulatory issue. Frontiers in oncology, 11, 641450. https://doi.org/10.3389/fonc.2021.64145
Mascolo, A., Scavone, C., Bertini, M., Brusco, S., Punzo, F., Pota, E., … & Rossi, F. (2020). Safety of anticancer agents used in children: a focus on their off-label use through data from the spontaneous reporting system. Frontiers in pharmacology, 11, 621. https://doi.org/10.3389/fphar.2020.00621
Pratico, A. D., Longo, L., Mansueto, S., Gozzo, L., Barberi, I., Tiralongo, V., … & Drago, F. (2018). Off-label use of drugs and adverse drug reactions in pediatric units: a prospective, multicenter study. Current drug safety, 13(3), 200-207. https://doi.org/10.2174/1574886313666180619120406
Rusz, C. M., Ősz, B. E., Jîtcă, G., Miklos, A., Bătrînu, M. G., & Imre, S. (2021). Off-Label Medication: From a Simple Concept to Complex Practical Aspects. International Journal of Environmental Research and Public Health, 18(19), 10447. https://doi.org/10.3390/ijerph181910447
Yackey, K., Stukus, K., Cohen, D., Kline, D., Zhao, S., & Stanley, R. (2019). Off-label medication prescribing patterns in pediatrics: an update. Hospital Pediatrics, 9(3), 186-193. https://doi.org/10.1542/hpeds.2018-0168
Consider the following scenarios:
1. Adhya is a 17 year old Indian-American female with a history of leukemia. The parents discussed a bone marrow transplant with the oncologist. The treatment could result on Adhya ‘s infertility. The treatment has not been discussed with her neither the risk. She has not been given the option to look for methods to preserve fertility. What would you do as her Nurse practitioner in the Oncology practice.
2. A 10 year old is admitted to the hospital after a high fall in the State Fair. He has multiple internal injuries requiring surgery and possible blood transfusions. The parents who are Jehova Witness are refusing the transfusion and prefer to continue resuscitation with fluid. The parents offer you to sign a waiver of liability to the hospital in case of the child death. You are the Emergency Department Nurse Practitioner coordinating the surgery. What’s your response?
select one scenario for the assignment
Write a 1-page narrative in APA format that addresses the following:
Explain the circumstances under which children should be prescribed drugs for off-label use. Be specific and provide examples.
Describe strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence. Include descriptions and names of off-label drugs that require extra care and attention when used in pediatrics.
Explain strategies for making off-label use and dosage of drugs safer for children from infancy to adolescence and descriptions and names of off-label drugs that require extra care and attention when used in pediatrics. Be specific.
Please use the rubric to formulate your assignment.