Pediatrics Case Study Assignment

Pediatrics Case Study Assignment

The circumstances for prescribing drugs for off-label use by children

Off-Label Use of drugs occurs when patients are given drugs by doctors without the approval of the Food and Drugs Administration (FDA). A patient is sometimes given drugs that were approved to treat another condition that is different from theirs. According to research, three-fourths of prescribed drugs do not have pediatric use information (Frattarelli et al., 2014).In most cases, children are the main victims of off-label drugs prescription due to unavoidable reasons. One of the reasons is that doctors tend to think that a specific drug is effective to a child even if it is not yet approved by the FDA.

This mainly happens because information on drug use in children is rarely found, and therefore this gives health workers a hard time. Off-label drugs are useful in saving children’s lives (Jain et al., 2017). Some diseases like Asthma and Allergies do not have a specific medication for curing the patient but, doctors have prescribed some children to off-label use of drugs in such cases, and the patients tend to show much improvement. For example, there was evidence that showed that aspirin could prevent a second heart attack, and doctors prescribed it as off-label. It was effective, but it took a long time before it was approved.

Strategies for making off-label drugs safer for Children

Off-label drugs are commonly used by many pediatrics in the world, and so there is a need to make them safer for use. There are various strategies that can be used to make off-label drugs safer. One of the strategies is by controlling and managing the promotion of drugs such as prazosin. When it is controlled, the drugs will be used in a minimal number. Another way of making the off-label drugs safer is by creating awareness about the drugs, telling people the advantages and the disadvantages of using the drugs (Pandolfini & Bonati 2016).

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Another strategy is by reducing the promotion of off-label drugs at the manufacturer level; this is effective because if they are not manufactured, they will not be available in the market for consumption. The restriction is always another way of dealing with off-label drugs such as clomiphene; for example, if strict safety measures are used, people will not use the drugs (W’t Jong et al., 2015). The government also can help in this by banning the use of off-label memantine drugs and enacting laws that can help to address this issue; nothing tends to be more effective than law.

References

Frattarelli, D. A., Galinkin, J. L., Green, T. P., Johnson, T. D., Neville, K. A., Paul, I. M., & Van,

567. D. A. (2014). Off-label use of drugs in children. Pediatrics, 133(3), 563-567.

Jain, S. S., Bavdekar, S. B., Gogtay, N. J., & Sadawarte, P. A. (2017). Off-label drug use in

children. The Indian Journal of Pediatrics, 75(11), 1133.

Pandolfini, C., & Bonati, M. (2016). A literature review on off-label drug use in

children. European journal of pediatrics, 164(9), 552-558.

W’t Jong, G., Vulto, A. G., de Hoog, M., Schimmel, K. J., Tibboel, D., & van den Anker, J. N.

(2015). A survey of the use of off-label and unlicensed drugs in a Dutch children’s hospital. Pediatrics, 108(5), 1089-1093.

Week 11 – Discussion Off-Label Drug Use in Pediatrics The unapproved use of approved drugs, also called off-label use, with children is quite common. This is because pediatric dosage guidelines are typically unavailable since very few drugs have been specifically researched and tested with children. When treating children, prescribers often adjust dosages approved for adults to accommodate a child’s weight. However, children are not just “smaller” adults. Adults and children process and respond to drugs differently in their absorption, distribution, metabolism, and excretion.

Children even respond differently during stages from infancy to adolescence. This poses potential safety concerns when prescribing drugs to pediatric patients. As an advanced practice nurse, you have to be aware of safety implications of the off-label use of drugs with this patient group. To prepare: Review the Bazzano et al. and Mayhew articles in the Learning Resources. Reflect on situations in which children should be prescribed drugs for off-label use. Think about strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence. Consider specific off-label drugs that you think require extra care and attention when used in pediatrics. With these thoughts in mind: By Day 3 Post an explanation of circumstances under which children should be prescribed drugs for off-label use.

Then, 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. By Day 6 Read a selection of your colleagues’ responses and respond to at least two of your colleagues on two different days who provided a different rationale than you did, in one or more of the following ways: Offer and support an alternative perspective using readings from the classroom or from your own research in the Walden Library. Validate an idea with your own experience and additional research.

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The use of off-label medications is a common practice in pediatric patients. The practice is associated with increased risk of harm to the patients because of inadequate evidence-based data on their use. Therefore, this paper examines circumstances that may lead to off-label prescribing to pediatric patients and safety strategies to be considered.

Circumstances

There are circumstances under which children should be prescribed off-label medications. One of them is a situation where the healthcare providers are managing unapproved disorder that does not have approved medications. In such cases, physicians prescribe medications that have proven effective among the adult populations for a similar disorder at a lower dose. The other circumstance is when the healthcare practitioners have in-depth understanding of the pediatric patients’ disease process and the effectiveness of off-label drugs.

They prescribe off-label medications to benefit the patients while utilizing their professional judgment to improve the care outcomes in pediatric patients (van der Zanden et al., 2021). For example, physicians prescribe ketamine for pediatric patients admitted to the intensive care unit despite it not being a FDA-approved drug of choice for this population.

Strategies

Healthcare practitioners should consider several strategies to ensure that off-label drugs are safe for children from infancy to adolescence. One of the strategies is by relying on the existing evidence when prescribing the off-label medications. Practitioners should critique the evidence obtained from high-quality studies and use them to inform their prescription decisions when treating pediatric patients. The other strategy is by considering ethics of practice. The decisions to treat pediatrics with off-label drugs should be informed by the principles of ensuring safety, justice, and quality outcomes for the patients (García-López et al., 2020; Hoekstra & Dietrich, 2022).

The other strategy is considering the influence of patient factors such as age on the pharmacological processes of the drugs prescribed to pediatric patients. The pharmacodynamic and pharmacotherapeutic processes in adult differ from that seen in pediatric patients. Therefore, practitioners should make decisions such as lowering the dosage and frequency of off-label medications as compared to adult doses to ensure safety and quality outcomes (Hoon et al., 2019). Some of the off-label drugs that should be prescribed with care for pediatric patients include hydromorphone, ketamine, and dexmedetomidine, which can be fatal is poorly used.

Conclusion

            In conclusion, off-label medications are largely used in pediatric patients. The use is attributable to the lack of adequate data on the efficacy of different treatments for pediatric conditions. Practitioners should consider strategies for ensuring safety in the prescription of off-label medications. In addition, they should make their treatment decisions based on evidence-based data and guidelines.

References

García-López, I., Cuervas-Mons Vendrell, M., Martín Romero, I., de Noriega, I., Benedí González, J., & Martino-Alba, R. (2020). Off-label and unlicensed drugs in pediatric palliative care: A prospective observational study. Journal of Pain and Symptom Management, 60(5), 923–932. https://doi.org/10.1016/j.jpainsymman.2020.06.014

Hoekstra, P. J., & Dietrich, A. (2022). First do no harm: Use off-label antipsychotic medication in children and adolescents with great caution. European Child & Adolescent Psychiatry, 31(1), 1–3. https://doi.org/10.1007/s00787-022-01950-7

Hoon, D., Taylor, M. T., Kapadia, P., Gerhard, T., Strom, B. L., & Horton, D. B. (2019). Trends in off-label drug use in ambulatory settings: 2006–2015. Pediatrics, 144(4), e20190896. https://doi.org/10.1542/peds.2019-0896

van der Zanden, T. M., Mooij, M. G., Vet, N. J., Neubert, A., Rascher, W., Lagler, F. B., Male, C., Grytli, H., Halvorsen, T., de Hoog, M., & de Wildt, S. N. (2021). Benefit-risk assessment of off-label drug use in children: The bravo framework. Clinical Pharmacology & Therapeutics, 110(4), 952–965. https://doi.org/10.1002/cpt.2336