Assignment: Off-Label Drug Use in Pediatrics

Assignment: Off-Label Drug Use in Pediatrics

Assignment: Off-Label Drug Use in Pediatrics

Off-label drug use refers to prescribing an FDA-approved drug for non-indicated use. Clinicians usually prescribe a drug for an unapproved use after they deem it medically appropriate for a specific patient. The purpose of this paper is to explore off-label drug use in pediatrics.

Circumstances to Prescribed Drugs for Off-Label Use in Children

Drugs should be used for off-label use in children if there is evidence supporting the drug’s efficacy and safety in treating the specific condition in pediatrics. The drug should have been evaluated by the expert group on off-label drug use and approved by the pharmacy administration committee (Meng et al., 2022). Most importantly, the benefits of off-label use should outweigh the risk for pediatric patients. For instance, the clinician should assess the potential benefits and risks of prescribing the drug to a child and ensure that the benefits outweigh the risks (Rusz et al., 2021). The clinician should also prescribe a drug for off-label use after obtaining informed consent from the caregiver and making a plan for monitoring adverse drug reactions (ADRs).

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Strategies to Make the Off-Label Use and Dosage of Drugs Safer For Children

Off-label use can be made safer for pediatrics by ensuring that their recommendations in pediatric guidelines are founded on a reliable methodological framework. An off-label drug database can be established and updated regularly, where clinicians can refer to it before prescribing to identify potential benefits and ADRs, promoting patient safety (Meng et al., 2022). Providing information on the risks of off-label drugs can encourage health providers to appropriately prescribe and use off-label medications for pediatrics. Off-label medications requiring extra care and attention in pediatrics include cardiovascular system drugs (Amlodipine, dopamine), sedatives (lorazepam, ketamine), fentanyl, oxycodone, and hydromorphone (Allen et al., 2018).

Conclusion

Drugs for off-label use should be prescribed in children if they are supported by evidence, evaluated by the expert group, and if the benefits outweigh the risks. Off-label use can be made safe in pediatrics by having a reliable methodological framework and a regularly updated database. Sedatives and CVS drugs should be used with caution in off-label use in children.

References

Allen, H. C., Garbe, M. C., Lees, J., Aziz, N., Chaaban, H., Miller, J. L., Johnson, P., & 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.

 Meng, M., Zhou, Q., Lei, W., Tian, M., Wang, P., Liu, Y., Sun, Y., Chen, Y., & Li, Q. (2022). Recommendations on Off-Label Drug Use in Pediatric Guidelines. Frontiers In Pharmacology, 13, 892574. https://doi.org/10.3389/fphar.2022.892574

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

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Evaluate the practice of prescribing off-label drugs to children
Analyze strategies to make the off-label use of drugs safer for children
Identify key terms, concepts, and principles related to prescribing drugs to treat patient disorders

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.

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
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 interactive media
Therapy for Pediatric Clients with Mood Disorders
An African American Child Suffering from Depression
BACKGROUND INFORMATION
The client is an 8-year-old African American male who arrives at the ER with his mother. He is exhibiting signs of depression.

 Client complained of feeling “sad”
 Mother reports that teacher said child is withdrawn from peers in class
 Mother notes decreased appetite and occasional periods of irritation
 Client reached all developmental landmarks at appropriate ages
 Physical exam unremarkable
 Laboratory studies WNL
 Child referred to psychiatry for evaluation

MENTAL STATUS EXAM
Alert & oriented X 3, speech clear, coherent, goal directed, spontaneous. Self-reported mood is “sad”. Affect somewhat blunted, but child smiled appropriately at various points throughout the clinical interview. He denies visual or auditory hallucinations. No delusional or paranoid thought processes noted. Judgment and insight appear to be age appropriate. He is not endorsing active suicidal ideation but does admit that he often thinks about himself being dead and what it would be like to be dead.
You administer the Children’s Depression Rating Scale, obtaining a score of 30 (indicating significant depression)
DECISION POINT ONE
Select what you should do:

Begin Zoloft 25 mg orally daily
RESULTS OF DECISION POINT ONE
 Client returns to clinic in four weeks
 No change in depressive symptoms at all
DECISION POINT TWO
INCREASE DOSE TO 37.5MG ORALLY DAILY
 Client returns to clinic in four weeks
 Depressive symptoms decrease by 20%. Client reports feeling a little bit better

Or increase dose to 50mg orally daily
Results
 Client returns to clinic in four weeks
 Depressive symptoms decrease by 50%. Client tolerating well

DECISION POINT THREE
MAINTAIN CURRENT DOSE
Guidance to Student
At this point, sufficient symptom reduction has been achieved. This is considered a “response” to therapy. Can continue with current dose for additional 4 week to see if any further reductions in depressive symptoms are noted. An increase in dose may be warranted since this is not “full” remission- Discuss pros/cons of increasing drug dose with client at this time and empower the client to be part of the decision. There is no indication that the drug therapy should be changed to an SNRI at this point as the client is clearly responding to this therapy.
Or change to Prozac 10mg orally daily
Results

 Client returns to clinic in four weeks
 No change at all in symptom

Increase to 20mg

Guidance to Student

The client has been on a sub therapeutic dose of Prozac- low dosing is appropriate for up to the first week of therapy in an attempt to minimize side effects, but after that, a therapeutic dose should be achieved. Therefore, increasing to 20 mg orally daily is appropriate. There is no indication to change to another SSRI or SNRI as the client has not had an adequate trial of this medication at a therapeutic dose. – should stick with one antidepressant for a sufficient trial of therapy at optimized dose- frequent changes not recommended at sub-therapeutic doses.

Attempt a different SSRI

Guidance to Student

The client has been on a sub therapeutic dose of Prozac- low dosing is appropriate for up to the first week of therapy in an attempt to minimize side effects, but after that, a therapeutic dose should be achieved. Therefore, increasing to 20 mg orally daily is appropriate. There is no indication to change to another SSRI or SNRI as the client has not had an adequate trial of this medication at a therapeutic dose. – should stick with one antidepressant for a sufficient trial of therapy at optimized dose- frequent changes not recommended at sub-therapeutic doses.

Situation two

BEGIN PAXIL 10 MG ORALLY DAILY

 Client returns to clinic in four weeks
 Reduction in The Children’s Depression Rating Scale by 5 points overall, but with complaints of nausea, vomiting, and diarrhea
Decision point two
decrease dose for 7 days then return to previous 10mg day dose
Result
 Client returns to clinic in four weeks
 Nausea, vomiting, diarrhea subsides with dose reduction, but returns with reinitiation of 10 mg dose
Increase dose to 20mg orally daily
Results
 Client returns to clinic in four weeks
 Nausea, vomiting, and diarrhea has increased and client is refusing to take medication

Decision point three
Discontinue Paxil and begin Prozac 10mg PO daily
Guidance to Student
Temporarily decreasing the drug for 7 days and then increasing is an acceptable option- however, if the side effects return with the reinitiation of the dose, you will need to select a different agent as these side effects are unfavorable to the client and may result in continued refusal to take treatment. Changing to a different SSRI may be appropriate if the trial decrease of dose is unsuccessful and if the nausea, vomiting, and diarrhea return with reinitiation of 20 mg orally daily. Changing the medication may be appropriate as not all SSRIs have the same side effect profile in all clients.

Attempt to decrease dose for another 7 days, then return to 10mg day dose
Change to Prozac 10mg orally daily
Results
 There is a 25% reduction in symptoms, client’s side effects of nausea, vomiting, and diarrhea have resolved. Client reports that he is feeling a “little bit better”
 Client returns to clinic in four weeks

Increase dose to overcome side effects.
Change to a different SSRI
Guidance to Student

Temporarily decreasing the drug for 7 days and then increasing is an acceptable option- however, if the side effects return with the reinitiation of the dose, you will need to select a different agent as these side effects are unfavorable to the client and may result in refusal to take treatment. Also, continuing to drop medication dose to subtherapeutic level will do minimal to treat depressive symptoms. Changing to a different SSRI would be the ideal choice as not all SSRIs have the same side effect profile in all clients. It would not be appropriate to increase the dose at this time as it would most likely result in increased intensity of side effects.