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Recommendations on Off-Label Drug Use in Pediatric Guidelines

Recommendations on Off-Label Drug Use in Pediatric Guidelines

Unapproved use of an approved drug, as described in week eleven, is commonly referred to as “off-label” use. This term can imply that the drug is used to treat a disease or medical condition not approved to treat. Examples include chemotherapy drugs approved to treat one type of cancer but used to treat another type of cancer by physicians. Using these drugs is not illegal, but when misused, it can result in various side effects, including death (Gupta & Nayak, 2014). The main goal of this discussion is to explain the circumstances under which children can be prescribed drugs for off-label use. The second part of the discussion describes techniques for making off-label drug use and dosage safer for children from infancy to adolescence, as well as describes and names some off-label drugs that require extra care and attention when used in pediatrics. The conditions under which children should be prescribed off-label drugs.

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Why would a medical provider or physician prescribe a medication for a purpose other than its intended use? Without an approved drug or when all approved treatment options have been exhausted, a healthcare professional, such as a nurse, may be guided by ethical principles to prescribe off-label drugs to a child to treat a condition. This could save the child’s life because, without these off-label uses, the condition’s symptoms worsen and become fatal (Wertheimer, 2011).

Second, pediatric patients are less likely to participate (or be well represented) in most clinical trials to determine a drug’s efficacy. As a result, there are fewer approved drugs for children. As a result, it may become necessary to prescribe Off-Label Drugs.

Strategies for making off-label drug use and dosage safer for children from infancy to adolescence

The first strategy for making these drugs safer is to ensure they are only prescribed for indications in the patient’s best interests. Second, healthcare professionals, such as nurses, should learn about using OLDU and weigh the risks and benefits before prescribing these drugs and providing the best possible care to patients.

Second, clinical trials on off-label use should be conducted where patients can participate (Gupta & Nayak, 2014). Before off-label drug uses are prescribed to children, several clinical trials can be conducted to test their safety and effectiveness. Finally, informed consent is required. The prescriber should inform the child’s family about the evidence supporting the drug recommendation.

Off-label drugs include asthmatic drugs such as Beclomethasone, used in infants under 12 months to prevent and control asthma symptoms (such as wheezing and shortness of breath). Morphine, another example, treats pain in children (Aamir et al., 2017).

Overall, if used correctly, there is no illegality in using Off-Label Drugs. However, healthcare professionals should only prescribe an off-label medication if there is sufficient evidence that it will benefit the child.

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References

Neville, K. A., Frattarelli, D. A. C., Galinkin, J. L., Green, T. P., Johnson, T. D., Paul, I. M., & Van, A. J. N. (January 01, 2014). Off-label use of drugs in children. Pediatrics, pp. 133, 3, 563–567.

Gupta, S. K., & Nayak, R. P. (January 01, 2014). Off-label use of medicine: Perspective of physicians, patients, pharmaceutical companies and regulatory authorities. Journal of Pharmacology & Pharmacotherapeutics, pp. 5, 2, 88–92.

Aamir, M., Khan, J. A., Shakeel, F., & Asim, S. M. (January 01, 2017). Unlicensed and off-label use of drugs in pediatric surgical units at tertiary care hospitals of Pakistan. International Journal of Clinical Pharmacy, pp. 39, 4, 860–866.

Wertheimer, A. (January 01, 2011). Off-label prescribing of drugs for children. Current Drug Safety, pp. 6, 1, 46–8.

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1-page narrative in APA format that addresses the following:

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