Off-Label Drug Use In Pediatrics Essay Example

Assignment: 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.  Off-Label Drug Use In Pediatrics Essay Example

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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 interactive media piece in this week’s Resources and reflect on the types of drugs used to treat pediatric patients with mood disorders.
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.  Off-Label Drug Use In Pediatrics Essay Example
By Day 5 of Week 11
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.
Reminder: The College of Nursing requires that all papers submitted include a title page, introduction, summary, and references. The Sample Paper provided at the Walden Writing Center offers an example of those required elements (available at http://writingcenter.waldenu.edu/57.htm). All papers submitted must use this formatting.

Off-label drug use among pediatrics has continuously been used for an extended period of time not only in the US, but also all over the world. Off label drugs refers to prescription of drugs which have not been scientifically proven to be effective for the illness being prescribed for. The effects of most of these drugs are therefore unpredictable since their reactions may vary from one individual to the other. The aim of this paper is to look at the circumstances under which off label drugs should be used in pediatrics as well as the strategies that can be implemented to ensure the safety of these drugs among children.

Explain the circumstances under which children should be prescribed drugs for off-label use. Be specific and provide examples.

The various existing reasons for the use of off label medications include existence of illnesses among children which lack any approved medication or treatment procedure. Lack of sufficient knowledge concerning pediatric is also another factor that has so much contributed to utilization of off-label drugs (Balan, Hassali & Mak, 2018). Due to their characteristic of having variations in needs, off-label drugs react differently in different patients. Therefore, there is need for healthcare providers and health researchers to collaborate towards studying the medications and making quality decisions of prescribing these off-label drugs. Failure of standard treatment in the country has also contribute so much on off-label drugs use. It is therefore the mandate of the government to provide healthcare insurance for every citizen to minimize the use of these off-label medications. Having insufficient alternative therapeutic approaches as well as lack of enough clinical trials among the pediatric population has also influenced the use of off label drugs positively (Yackey et al., 2019). It is through conducting these clinical trials and seeking alternative types of therapies that the safety, dosage and efficacy of any given medication can be determined. Some of the circumstances where off label drugs can be administered to children include during emergency period. For instance, if a child mistakenly encounters food poisoning and immediately taken to the hospital, the available healthcare provider may opt to offer an off label medication for pain reduction as they wait for further help. The healthcare provider may also consider administering the off label medication if there is sufficient evidence of the drug’s efficacy in such cases. For example, a healthcare provider may decide to use a chemotherapy known to treat only one type of cancer to treat other types of cancer.  Off-Label Drug Use In Pediatrics Essay Example

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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

There are numerous off label medications used by healthcare providers but lack sufficient scientific evidence of their influence towards the condition/illness they are prescribed for. There are different strategies that can be incorporated towards enhancing the safety of off label drug use. The first strategy is inclusion of a more detailed Summary of Product Characteristics in all medications. All pharmaceutical companies involved in medication production should ensure efficacy tests on their products, effectiveness on adults and the behavior of their medication in terms of pharmacokinetics (Allen et al., 2018). The other strategy is conducting intensive research concerning off label drug use among children which will help in production of more effective medications for children, thus boosting their health. Research will further facilitate production of high quality medication as well as helping in the approval process by the FDA.

The use of off label drugs however does not necessarily imply that they are all unsafe for consumption. These drugs are greatly prescribed by many healthcare providers all over the world and hence the need for the parents to understand them before allowing their children to use. It is therefore the duty of a healthcare provider to inform the parent all the benefits and drawbacks of using any given off label drug for the parent to make informed decisions. Some of the major used off label drugs on pediatrics include antihistamines, antibiotics and antidepressants. For instance, most healthcare providers recommend the use of antihistamines in treatment of respiratory infections among children. Drugs such as cancer drugs and antidepressants used in treatment of chronic diseases are some of the off label drugs that require extra care and attention when used in children (Pratico et al., 2018). For example, Amoxicillin and morphine highly require extra attention when used as pain relievers in children. The use of a Summary of Product Characteristics should therefore be encouraged in these two medications to ensure that a proper measure of dosage is indicated.

In a recap, drugs being off label does not necessarily mean that they are dangerous. However, being off label puts the patients at risk of developing conditions that might be brought through taking a medication that does not match one’s illness. The healthcare providers should therefore always strive to make informed decisions before offering any off label medication to a patient. However different circumstances such as lack of any known medication to cure specific pediatric illnesses makes most healthcare providers to recommend off label drugs. Some of the strategies that can be made is to always encourage the use of a Summary of Product Characteristics in off label medications to facilitate the safety of these off label medications.

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 Association111(8), 776.

PMID: 31379392

Balan, S., Hassali, M. A. A., & Mak, V. S. (2018). Two decades of off-label prescribing in

children: a literature review. World Journal of Pediatrics14(6), 528-540.

https://doi.org/10.1007/s12519-018-0186-y

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 safety13(3), 200-207.

https://doi.org/10.2174/1574886313666180619120406

Yackey, K., Stukus, K., Cohen, D., Kline, D., Zhao, S., & Stanley, R. (2019). Off-label

medication prescribing patterns in pediatrics: an update. Hospital Pediatrics9(3), 186-

  1. https://doi.org/10.1542/hpeds.2018-0168

Off-Label Drug Use In Pediatrics Essay Example

 

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