Discussion: Off-Label Drug Use In Pediatrics

Discussion: Off-Label Drug Use In Pediatrics

A Sample Answer For the Assignment: Discussion: Off-Label Drug Use In Pediatrics

Off-label drug use among children is when prescription medications are used to treat conditions not approved for use by the Food and Drug Administration; this practice is widespread; nearly half of the drugs prescribed to kids are used off-label (Meng et al., 2022; Allen et al., 2018). However, its safety and effectiveness remain highly controversial.This paper addresses specific instances when children should receive off-label use drugs as well as strategies that make this practice safer for infants to adolescents.

Circumstances for Prescribe Drugs for Off-Label Use in Children

Children may sometimes require off-label drugs to treat certain conditions effectively. A good example of this is the use of Fluoxetine for OCD, even though the FDA has not approved them for treatment of this disorder (Shuib et al., 2021). Antipsychotic medication could also prove helpful against severe behavioral problems associated with Autism or ADHD, even though only intended for adult treatment.

Off-label drugs may also be prescribed when there are no approved treatments available to pediatric patients; such as when cancer drugs approved by adult medicine have not been studied on children who also suffer from that form of cancer; healthcare providers must carefully weigh potential risks against benefits to ensure that any medication prescribed meets all standards in terms of patient safety and satisfaction.

Strategies for Safer Off-Label Use in Children

Various approaches should be employed when prescribing off-label drugs to children to ensure their safety and efficacy. One strategy involves closely tracking a patient’s medication response and making appropriate dosage changes (Meng, Zhou, et al., 2022). Another strategy might involve pairing the drug with additional therapies like behavioral or psychotherapy sessions for optimal effectiveness and reducing the prescribed dose. Finally, healthcare providers must factor in age, weight and overall health status when prescribing an individualized dosage schedule for every child they treat.

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Healthcare providers must exercise extreme care when prescribing off-label drugs to pediatric patients. Opioids like codeine and tramadol that could potentially cause respiratory depression in young children must only be prescribed with consultation from healthcare professionals beforehand, while antibiotics such as tetracyclines have the potential of discoloring tooth enamel; all must be considered carefully to ensure safe and effective off-label drug usage among pediatric patients (Meng, Zhou, et al., 2022). By considering such factors, healthcare providers can ensure the safe and effective usage of off-label medicines among pediatric patients.

Conclusion

Off-label drug usage by children remains a controversial subject. They may be necessary in certain instances; however, when making this decision it should be approached carefully. While limited research exists regarding their safety and efficacy in kids, this might be their only treatment option in certain instances. Healthcare providers must carefully weigh the potential risks and benefits of off-label drug usage among children before prescribing.

When administering off-label medicines to kids, various strategies can be employed to safeguard safety and efficacy. One strategy involves closely tracking how well patients react to the medication and making any necessary dosage adjustments accordingly. Another tactic involves using medication alongside behavioral or psychotherapeutic therapies as complementary measures.

When determining an ideal dosage regimen, healthcare providers should also factor in the child’s age, weight, and health status. Being essential in expanding the evidence base and safety when prescribing off-label medicines to children. As research progresses, it is paramount that healthcare practitioners remain diligent in assuring the safe and effective use of off-label medications within pediatric populations.

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., Lv, M., Wang, L., Yang, B., Jiao, P., Lei, W., Lan, H., Shen, Q., Luo, X., Zhou, Q., Yu, X., Xun, Y., Lei, R., Hou, T., Chen, Y., & Li, Q. (2022). Off-label use of drugs in pediatrics: a scoping review. European Journal of Pediatrics, 181(9), 3259–3269. https://doi.org/10.1007/s00431-022-04515-7

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

Shuib, W., Wu, X.-Y., & Xiao, F. (2021). Extent, reasons and consequences of off-labeled and unlicensed drug prescription in hospitalized children: a narrative review. World Journal of Pediatrics: WJP, 17(4), 341–354. https://doi.org/10.1007/s12519-021-00430-3

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

‌Respond # 1

I really enjoyed reading your post. Just to piggyback on what you said, the patient is probably experiencing premenopausal symptoms evident by hot flash, night sweats, and genitourinary symptoms. According to Smail et al. (2019), menopause is the period from when a woman has stopped menstruating for a period of twelve conservative months.

Smail 2019 explains that during this time there is drop in the production of the ovarian hormones’ estrogen and progesterone leading symptoms and diseases like vaginal infections, increased risk for osteoporosis and cardiovascular diseases, sleep disorders, mood alterations, hot flashes, depression, and urinary tract infections. Roberts & Hickey (2016) also discusses that during menopause common findings such as genitourinary syndrome of menopause, sleep disturbances, vasomotor symptoms (VMS), and mood disturbances are common.

Treatment Regimen Choice or Pharmacotherapeutics Recommendation

To control the patient blood pressure and the patient’s obesity, I will encourage patient to keep to current medication prescription regimen, make lifestyle changes, and monitor blood pressure reading regularly. VMS treatments would be based on how disturbing the symptoms are (Roberts & Hickey, 2016). Currently the most effective treatment for VMS is moderate dose estrogen-containing hormone therapy (HT), and that also improves vaginal dryness (Roberts & Hickey).

They also explain that to help reduce VMS, SSRI such as escitalopram is a reasonable first choice since it is well tolerated. I will prescribe transdermal estradiol patch, spray, or gel. The patch will be applied to the skin of the trunk, or the spray to apply once daily to the forearm or the gel to apply once daily to one arm, from the shoulder to the wrist or to the thigh (Rosenthal & Burchum, 2018). when used for VMS, escitalopram reduces the frequency, severity and improves quality of life, improves sleep, and does not cause sexual dysfunction (Rosenthal & Burchum). Transdermal formulations range of estrogen absorption is from 14 to 60 mcg/24 hr, depending on the product employed (Rosenthal & Burchum).

Patient Education Strategy Recommendation

To help with the patient’s VMS, I will educate the patient on eating heart healthy food such as whole grains, vegetables, fruits, and maintain a normal level of vitamin D and Calcium (McCance & Huether, 2019). To manage the patient’s weight, I will encourage her to reduce the amount of processed foods, reduce salt intake, avoid or limit alcohol consumption, maintain a healthy weight, manage stress level and regular exercise weekly at least for thirty minutes daily (McCance & Huether).

Maintain good sleep pattern by avoiding caffeine, engage in bedtime relaxation rituals such as stay away from bright lights to reduce things that can cause excitement before bedtime and avoid eating large meals for at least two hours before bedtime (Fujimoto, 2017). Fujimoto explains that keeping to regular health maintenance such as pap smear test, mammograms, breast self-examination, cholesterol screening. Also, I will encourage the patient to take flu shot annually.

References

Fujimoto, K. (2017). Effectiveness of coaching for enhancing the health of menopausal Japanese women. Journal of Women & Aging, 29(3), 216–229. https://doi-org.ezp.waldenulibrary.org/10.1080/08952841.2015.1137434

 McCance, K. L. & Huether, S. E. (2019). Pathophysiology: The biologic basis for disease in adults and children (8th ed.). St. Louis, MO: Mosby/Elsevier. 

Rosenthal, L. D., & Burchum, J. R. (2018). Lehne’spharmacotherapeutics for advanced practice providers. St. Louis, MO: Elsevier.

Roberts H., & Hickey, M. (2016) managing the menopause: An update. Maturitas, 86(2016), 53-58. Retrieved from https://www-sciencedirect-com.ezp.waldenulibrary.org/science/article/pii/S037851221630007X?via%3Dihub

Smail, L., Jassim, G., & Shakil, A. (2019). Menopause-Specific Quality of Life among Emirati Women. International Journal of Environmental Research and Public Health, 17(1). https://doi-org.ezp.waldenulibrary.org/10.3390/ijerph170100