Posted: February 7th, 2022

Off-Label Drug Use in Pediatrics

Off-Label Drug Use in Pediatrics
The treatment of children and adolescents with mood disorder is often a critical aspect especially when it comes to medication. Such a situation is created by the probability of an off-label use where the pediatric dosage guidelines are not available thereby prompting the patient to engage in the unapproved use of approved drugs (Wimmer, Neubert & Rascher, 2015). For the African American 8-year old patient exhibiting signs of depression, critical therapeutic decisions have to be made concerning the administration of a prescription for the off-label drugs that would facilitate the effective management of their significant mood disorder.
There are distinct circumstances under which children and teenagers should be prescribed off-label drugs. For some children such as the 8-year old patient, their situation is considered to be significant in such a way that offering a prescription cannot be overlooked. In such a case, the healthcare provider ought to integrate consensual statements and comply with the policies and guidelines defined by the American Academy of Pediatrics (AAP). Since there might not be any data available on the administration of off-label drugs, the provider is obliged to establish the pediatric evidence-base depending on the respective situation (Czarniak et al., 2015). For instance, the patient from the case study portrays mood changes, lack of appetite, and poor sleeping patterns which mean that regulated amounts of serotorin would help to reduce the anxiety by relaying signals between the nerve cells in the brain.
To make off-label dosage and use of drugs safer for children, the doctors ought to produce detailed information to the parents or guardians to engage them closely. This is to ensure that the imminent medical and legal risks are fairly managed. The providers acquire substantial historical data of the patient and develop competent decision-making while prescribing (Poznanski & Morkos, 1996). Some of the off-label drugs that require extra attention for pediatrics are the stimulants and antidepressant medications that aim to improve the pediatrics’ ability to learn and focus by reducing impulsivity.
Overall, the administration of off-label drug use as well as their dosage is a relatively critical practice considering the implications that it could lead to in the event that the drugs are not used appropriately. As such, critical therapeutic decisions have to be made concerning the administration of a prescription for the off-label drugs.

References
Czarniak, P., Bint, L., Favié, L., Parsons, R., Hughes, J., & Sunderland, B. (2015). Clinical setting influences off-label and unlicensed prescribing in a paediatric teaching hospital. PloS one, 10(3).
Poznanski, E. O., & Mokros, H. B. (1996). Children’s depression rating scale, revised (CDRS-R). Los Angeles: Western Psychological Services.
Wimmer, S., Neubert, A., & Rascher, W. (2015). The safety of drug therapy in children. Deutsches Ärzteblatt International, 112(46), 781.

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Study Notes & Homework Samples: Executive Order 13873 »Evidence-Based Practices and Rehabilitation