NURS 6521 Week 10 Off-Label Drugs
According to the American Academy of Pediatrics (2014), less than half of medications have specific instructions for children, which leaves the provider to determine the appropriate treatment for the child. The term off-label use, means that the drug is being used for something that was not included in the package insert or approved labeling (Neville, 2014). NURS 6521 Week 10 Off-Label Drugs
Children are not like adults, as their age and weight change rapidly, which can affect dosing of medications, as can body fat, amount of water in a child’s body, plasma, and hormones (Mir, & Geer, 2016). Pharmacokinetics and pharmacodynamics differ in children as well, such as drug absorption and metabolism (Mir, & Geer, 2016). The use of off-label medications in children is done mainly because there are not enough available medications used to treat children (Mir, & Geer, 2016).
There has been recent and on-going concern regarding the use of SSRI antidepressants in children as they may cause a higher incidence of suicide ideation (National Institute of Mental Health [NIMH], n.d.). The Food and Drug Administration (FDA) has issued a black box warning for all SSRI antidepressants, for the potential increase in suicidal thoughts when taken by teens (NIMH, n.d.). Fluoxetine is currently the only SSRI antidepressant that is approved for adolescents ages 8-18 (Drugs.com, 2017). Venlafaxine has also been prescribed to kids, as an off-label treatment, although it has not been approved by the FDA for use in children (NIMH, n.d.). A placebo-controlled study was completed on 766 pediatric patients and the data gathered was not adequate enough to support the use of venlafaxine in children (Drugs.com, 2017). As well as the safety of the drug has not been evaluated beyond treatment longer than six months in children (Drugs.com, 2017). There are many drugs that need further evaluation and research done to clarify the efficacy in children, such as opioids and cardiovascular drugs (Kimland, 2012). NURS 6521 Week 10 Off-Label Drugs
Technology and electronics may play a role in the use of off-label drug use in children in the future. Computerized documentation, which can include measured outcomes, will assist in tracking the use and side effects of off-label drug use in children (Kimland, 2016).
References
American Academy of Pediatrics. (2014). AAP makes recommendation on off-label drugs forchildren. Retrieved from https://www.aap.org/en-us/about-the-aap/aap-press-room/Pages/AAP-Makes-Recommendations-On-Use-of-Off-Label-Drugs-for Children.aspx
Drugs.com. (2017). Amoxicillin. Retrieved from https://www.drugs.com/pro/amoxicillin.html NURS 6521 Week 10 Off-Label Drugs