Advanced Pharmacology
Running head: off-label drug use in pediatrics 1
off-label drug use in pediatrics 8
Off-Label Drug Use in Pediatrics
Walden University
NURS 6521 Advanced Pharmacology
October 25, 2019
Off-Label Drug Use in Pediatrics
The pediatric population is a special population when it comes to treating a variety of health issues. Sometimes it’s necessary to prescribe medications that have not been FDA approved to use in this population. Advanced practitioners need to know when and how to prescribe safely in these types of situations. This paper will address circumstances for prescribing off-labeled drugs in pediatrics, strategies for making use and dosages safer for pediatric patients and provide examples of off-label medications.
Circumstances for Off-Label Drug Use
An important reason for the off-label use of medication in children is the lack of licensing and effective and safe options to therapeutically treat a health condition. According to a policy statement in Pediatrics (2014), a medication used “off-label” does not mean it’s being used illegally, inappropriately, or on an investigational basis. So many drugs that are critical for treatment do not have data available for use in children. A provider’s decision to use certain medications in pediatric patients is based on their clinical judgment, the best evidence that is currently available and the importance of the benefit it will provide. The American Academy of Pediatrics (AAP) recognizes the importance of providers using off-label medications in children as it has resulted in over 500 labeling changes that include label use in children. (American Academy of Pediatrics, 2014).
Strategies for Safer Use of Off-Label Drugs
Children are not small adults and cannot be treated as such when it comes to prescribing medications. Adverse drug reactions in children are a result of overdosages, lack of monitoring, administrating despite contraindications or through inappropriate routes, poor communication, and labeling. (Wimmer, Neubert & Rascher, 2015). Drug disposition and dosage requirements in children are affected by weight, age, gender, surface area, diet, race, and body composition. These factors are all things that must be considered in order to make the safest decision on what to prescribe. An electronic prescribing system with clinical decision support recommended by the AAP includes databases to calculate appropriate pediatric dosages, warn of risks and contraindications and teaching pediatric pharmacology. (Wimmer, Neubert & Rascher, 2015).
MedWatch is another way to implement safer use of off-label medication in children. It’s a reporting program set up by the FDA to report safety issues and adverse effects of medications. This can help track what works and what doesn’t among this vulnerable population.
Common Drugs Used Off-Label in Children
Some examples of drugs used off-label in children include sildenafil, a vasodilator, used for pulmonary hypertension; clonidine, an antihypertensive, used in children to treat ADHD; morphine, a narcotic, used for severe pain in children. (Nabi Mir & Ishaq Geer, 2015).
Summary
It may be necessary for some situations to prescribe a medication to a child that has not been approved for use. Providers need to be mindful that children are not small adults and can not be treated as such. Age, weight, and surface area are just a few things that need to be considered when prescribing off-label medications. It’s also important that they use careful clinical judgment along with other available resources when deciding the best course of treatment.
References America Academy of Pediatrics. (2014, February 24). AAP Makes Recommendations on Use of Off-Label Drugs for Children. 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. Nabi Mir, A., & Ishaq Geer, M. (2015). Off-Label Use of Medicines in Children | International Journal of Pharmaceutical Sciences and Research. Retrieved 27 October 2019, from http://ijpsr.com/bft-article/off-label-use-of-medicines-in-children/ Pediatrics. (2014, March 1). Off-Label Use of Drugs in Children. Retrieved from https://pediatrics.aappublications.org/content/133/3/563. Wimmer, S., Neubert, A., & Rascher, W. (2015, November 13). The Safety of Drug Therapy in Children. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4671328/.
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