Assignment: Off -Label Drug Use in Pediatrics Essay

Assignment: Off -Label Drug Use in Pediatrics Essay

Assignment Off -Label Drug Use in Pediatrics Essay

Off-label use is the prescription of a drug that has a marketing authorization but using it for a condition, through a route or for an age group that is not indicated in its product characteristics. The use of drugs outside the specifications listed in its license in terms of the medicine’s formulation, indications, and contraindications is referred to as off-label and off-license use (Mir & Geer, 2016). The present paper looks to examine the circumstances that can lead to children receiving off-label prescriptions as well as stratagems for making the off-label usage and dosage of the said drugs safer for children across all age groups.

The off-label use of drugs in the treatment of pediatric patients is common and occurs in children with medical and surgical conditions as well as the critically ill. Children should be prescribed off-label use only when there is substantial existing evidence that supports the use of a drug for a specific condition in a particular patient and should be in the form of two well-controlled studies (Czaja, Reiter, Schultz & Valuck, 2015). Moreover, Czaja, Reiter, Schultz and Valuck (2015) argue that it is important to produce evidence to support the successive requests by a drug sponsor to have a novel indication labelled. The prescribing clinician should obtain informed consent from the child’s caregiver and the benefits, anticipated risks and alternatives should be communicated (Tefera et al., 2017). Most importantly, the benefits of off-label use should outweigh the risk for pediatric patients.

Making Off-Label Dosage and Use Safe for Children

The off-label use can be made safer for pediatric populations by having the prescribing clinician being responsible for deciding the drug and dosing regimen a pediatric patient will receive and its purpose (Mir & Geer, 2016). The decision should be made based on the information provided in the drug’s label or other information available to the prescriber. In addition, when prescribing off-label drugs,

practitioners should rely on the best evidence and judgment available, especially from sources that contain evidence regarding a drug’s pediatric safety and use (Tefera et al., 2017). The relevant sources would encompass the MedWatch program by the FDA, Cochrane reviews, consensus statements from various professionals, practice guidelines from relevant agencies, AAP Polices as well as peer-reviewed literature (Mir & Geer, 2016). Physicians and practitioners can play a significant role in contributing to therapeutic data by publishing their experience with off-label use of drugs (Mir & Geer, 2016). The published information can be the basis of formal efficacy and safety studies and act as a therapeutic decision-making guide for other practitioners.

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Off-label drugs that should be used with caution in children include cardiovascular drugs, which may cause hemodynamic instability or impaired tissue perfusion when under- or overdosed. They include Amlodipine, Dopamine, Milrinone, and Lisinopril (Tefera et al., 2017). Drugs affecting the neurological system should also be used with caution as they may cause acute instability in the neurologic and cardiopulmonary status such as Fentanyl (Grant, Scoppettuolo, Wypij & Curley, 2012). Sedatives have been associated with longer-term adverse effects and should be used with extra caution in pediatrics. Examples of the sedatives include lorazepam, ketamine, and dexmedetomidine (Grant at al., 2012). Other off-label drugs that should be administered with extra care include methadone, oxycodone, hydromorphone, and bupivacaine.

Assignment: Off -Label Drug Use in Pediatrics Essay Conclusion

The reasons for using off-label drugs in children are varied. However, the primary aim of off-label use in pediatrics should be to benefit the individual patient, and the benefits should outweigh the risks. Off-label use in pediatrics should be used if there is substantial evidence from controlled studies supporting the use of the drug. The caregiver should also provide informed consent allowing the off-label drug to be used on the patient. Besides, the decision to use an off-label drug should be based on the information provided in the drug’s label and available evidence.

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 1 Paxil 10 mg after 2 weeks patient returned follow up finding: Client returns to the 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 2 Decrease dose for 7 days then return to previous 10 mg daily
3. Decision point 3 Change to a different SSRI
Rationale: 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 the 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.
Assignment
1. Explain the circumstances under which children should be prescribed drugs for off-label use. Be specific and provide examples.
2. Describe strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence.
3. Include descriptions and names of off-label drugs that require extra care and attention when used in pediatrics.
Appropriate conclusion

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).

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).

Assignment: Off -Label Drug Use in Pediatrics Essay 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.

Assignment: Off -Label Drug Use in Pediatrics Essay 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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Questions to Instructor Forum: This is a great place to ask course content or assignment questions. If you have a question, there is a good chance one of your peers does as well. This is a public forum for the class.

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Important information for writing discussion questions and participation

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Your initial discussion post should be a minimum of 200 words and response posts should be a minimum of 150 words. Be advised that I grade based on quality and not necessarily the number of words you post. A minimum of TWO references should be used for your initial post. For your response post, you do not need references as personal experiences would count as response posts. If you however cite anything from the literature for your response post, it is required that you cite your reference. You should include a minimum of THREE references for papers in this course. Please note that references should be no more than 5 years old except recommended as a resource for the class. Furthermore, for each discussion board question, you need ONE initial substantive response and TWO substantive responses to either your classmates or your instructor for a total of THREE responses. There are TWO discussion questions each week, hence, you need a total minimum of SIX discussion posts for each week. I usually post a discussion question each week. You could also respond to these as it would count towards your required SIX discussion posts for the week.

I understand this is a lot of information to cover in 5 weeks, however, the Bible says in Philippians 4:13 that we can do all things through Christ that strengthens us. Even in times like this, we are encouraged by God’s word that we have that ability in us to succeed with His strength. I pray that each and every one of you receives strength for this course and life generally as we navigate through this pandemic that is shaking our world today. Relax and enjoy the course!

Hi Class,

Please read through the following information on writing a Discussion question response and participation posts.

Contact me if you have any questions.

Important information on Writing a Discussion Question

• Your response needs to be a minimum of 150 words (not including your list of references)
• There needs to be at least TWO references with ONE being a peer reviewed professional journal article.
• Include in-text citations in your response
• Do not include quotes—instead summarize and paraphrase the information
• Follow APA-7th edition
• Points will be deducted if the above is not followed

Participation –replies to your classmates or instructor

• A minimum of 6 responses per week, on at least 3 days of the week.
• Each response needs at least ONE reference with citations—best if it is a peer reviewed journal article
• Each response needs to be at least 75 words in length (does not include your list of references)
• Responses need to be substantive by bringing information to the discussion or further enhance the discussion. Responses of “I agree” or “great post” does not count for the word count.
• Follow APA 7th edition
• Points will be deducted if the above is not followed
• Remember to use and follow APA-7th edition for all weekly assignments, discussion questions, and participation points.
• Here are some helpful links
• Student paper example
• Citing Sources
• The Writing Center is a great resource