Off-Label Drug Use in Pediatrics

In the United States, the FDA approves a drug for a certain set of uses after the drug has been put through rigorous studies. Once approved, the FDA and the drug manufacturer create the drug’s “label” which is an information document that details the drug’s specific approved uses. However, researchers may later discover that the drug can be used to treat other conditions. In this case, doctors may legally prescribe a drug to treat a condition not listed on the drug’s label. Thus, “off-label drug use” means to use a drug for a purpose not listed on the drug’s label. Typically, an ethical doctor will only prescribe a drug for off-label purposes when the benefits of use outweigh the risks. Credible medical evidence such as clinical trials and medical literature should also support the doctor’s decision.

 

Examples of off-label drugs

 

Drug (Brand name)                               Common on-label use                        Common off-label use

 

bupropion (Wellbutrin)             depression                        bipolar

 

diphenhydramine (Benadryl)        allergy sx, insomnia                N/V related to pregnancy

 

escitalopram (Lexapro)            depression, anxiety                bipolar

 

fluoxetine (Prozac)                depression, OCD, bipolar           autism spectrum disorders

 

montelukast (Singulair)            asthma                            COPD

 

quetiapine (Seroquel)              schizophrenia, bipolar              insomnia

 

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.

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.
  •  

Write a 2-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.

 

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Off-Label Drug Use in Pediatrics

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 Panther et al (2017) and Corney, Lebel, Bailey, and Bussieres (2015) 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:

Write Include sub headings plz. And purpose of writing.

· 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.

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Use the following coupon
"FIRST15"

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