Feb 23, 2024 Case-Assignment: Dosage of Drugs
Case-Assignment: Dosage of Drugs
Case-Assignment: Dosage of Drugs
Situations When Off Label Medications May be Used in Pediatrics
There are specific situations when medications in the regard of off-label medications can be given to children. For instance, whenever a drug which is meant to manage a particular condition has been used without demonstrable success, a physician can choose a different alternative to save the day (“Off-Label use of Medicines in Children,” n.d.). A physician may be compelled to prescribe a drug to a pediatric when a particular formulation is available in a different country in another possible scenario. Yet there are acute shortages in their areas of jurisdiction.
On the other hand, the physician can make an importation request for a drug used in another country for adults but for children in their country (Allen et al., 2018). Examples of the off-label medications used in children include amoxicillin, used for different conditions, including otitis media. There are specific medications which are high risk and should be used with caution in paediatrics, including dopamine, hydromorphone, oxycodone and lorazepam (Czaja et al., 2015). The medication could cause pronounced psychological effects or even unforeseen death.
Strategies for Off-label Medications for Pediatrics
Whenever off-label medications are used in children, there ought to be strategies to ensure they attain the best possible outcomes with minimal adverse effects. More clinical trials should be considered but within the safety and ethical parameters in children to establish the efficacy of medications (Tefera et al., 2017). The healthcare providers, the nurses, physicians and pharmacists should have efficient reporting methods and address the occurrence of adverse effects in children, which would then enhance the use of the medications.
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References
Allen, H. C., Garbe, M. C., Lees, J., Aziz, N., Chaaban, H., Miller, J. L., … DeLeon, S. (2018). Off-Label Medication use in Children, More Common than We Think: A Systematic Review of the Literature. The Journal of the Oklahoma State Medical Association, 111(8), 776–783. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/31379392
Czaja, A. S., Reiter, P. D., Schultz, M. L., & Valuck, R. J. (2015). Patterns of off-label prescribing in the pediatric intensive care unit and prioritizing future research. Journal of Pediatric Pharmacology and Therapeutics, 20(3), 186–196. https://doi.org/10.5863/1551-6776-20.3.186
OFF-LABEL USE OF MEDICINES IN CHILDREN | INTERNATIONAL JOURNAL OF PHARMACEUTICAL SCIENCES AND RESEARCH. (n.d.). Retrieved February 2, 2021, from https://ijpsr.com/bft-article/off-label-use-of-medicines-in-children/?view=fulltext
Tefera, Y. G., Gebresillassie, B. M., Mekuria, A. B., Abebe, T. B., Erku, D. A., Seid, N., & Beshir, H. B. (2017). Off-label drug use in hospitalized children: A prospective observational study at gondar university referral hospital, northwestern Ethiopia. Pharmacology Research and Perspectives, 5(2), 304. https://doi.org/10.1002/prp2.304
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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).
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,
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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