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Concept and Circumstances
Off-label drug use in pediatrics is a common occurrence but creates concerns for the safety of such practice. Drug dosage in pediatrics differs from regular adult prescriptions and depends on the age of the patient that impacts the rate of drug absorption, physiologic response and effects, and interaction with the disease. The off-label drug is the prescription of medication to populations such as pediatrics in dosages that are extrapolated from the standard label recommendations for adults. It is based on the assumption that pharmacokinetics and drug dosage will have the same effects in pediatric patients as in adults (Arcangelo, Peterson, Wilbur, & Reinhold, 2017).
Off-label drug use is not considered experimentation and does not require specific consent or review. Physicians should use professional judgment that takes into account a patient’s best interests. Off-label drug use is a public health issue, necessary in cases of a rare disease or severe symptoms in pediatric patients. The medical community as a whole agrees that practitioners should rely on evidence-based practice as a standard rather than label indications since less than 50% of medications have pediatric information (American Academy of Pediatrics, 2014). Essentially, off-label drug use is encouraged if it helps to achieve positive outcomes and does not create adverse side effects for the patient.
Until recently, it is estimated that only 20 percent of drugs were used in pediatrics in accordance with label standards. A series of drugs used in pediatrics adhere to the criteria of high frequency, elevated risk, and FDA priority. These include “dexmedetomidine, dopamine, hydromorphone, ketamine, lorazepam, methadone, milrinone, and oxycodone” (Czaja, Reiter, Schultz, & Valuck, 2015, p. 92). These high-priority substances are used for cardiovascular or neurological treatments. However, none of them have FDA approval to be used for pediatric patients. Nevertheless, despite the high-risk status, which may result in therapeutic failure or adverse outcomes, the off-label use rate remained at approximately 10% in the ICU alone (Czaja, Reiter, Schultz, & Valuck, 2015).
Problems with Off-Label
Off-label drug use creates an unregulated form of medical practice, which creates a myriad of potential issues. Due to unapproved use, the patient, especially in pediatrics, can have adverse effects. Increased incidences of adverse drug reactions are often associated with off-label use. There are numerous risks that cannot be considered without a proper trial, and a doctor cannot be expected to consider all pharmacokinetic intricacies of the drug. Furthermore, this creates a potential ethical and legal dilemma since a patient’s health may be at risk due to off-label use. Practitioners expose themselves to lawsuits, and their reputation may suffer due to such practices that have long-term ramifications (Corny, Lebel, Bailey, & Bussières, 2015).
From a financial standpoint, drug manufacturers benefit from off-label drug use. On-label data must be FDA-approved which is a lengthy and costly process that many companies do not feel justifies the expense (Wittich, Burkle, & Lanier, 2012). Overall, manufacturers encourage off-label drug use since it results in increased sales and profits. Meanwhile, physicians value and advocate the right to use off-label prescriptions in practice. Manufacturers take advantage of this in order to illegally promote and offer financial incentives for off-label drug use since revenue often exceeds penalties (Rodwin, 2015).
Due to challenges associated with off-label drug use, government agencies such as the FDA have begun to establish regulations and recommendations to increase clinical research for pediatric use. Furthermore, practitioners should collectively indicate to drug manufacturers the necessity to research and make available such information to protect ethical and medical standards of clinical practices. In the meantime, practitioners can directly engage with patients to improve awareness and safety for off-label uses. This includes sharing of information and gaining consent, using medications that have provided pediatric data, and maintaining careful records of patient reactions in order to evaluate the effect of off-label drug use in specific age groups (Corny et al., 2015). Overall, efforts should be made to create public and professional pressure on drug manufacturers to improve research and labeling processes.
American Academy of Pediatrics. (2014). Off-label use of drugs in children. Pediatrics, 133(3), 563-567. Web.
Arcangelo, V. P., Peterson, A. M., Wilbur, V., & Reinhold, J. A. (Eds.). (2017). Pharmacotherapeutics for advanced practice: A practical approach (4th ed.). Ambler, PA: Lippincott Williams & Wilkins.
Corny, J., Lebel, D., Bailey, B., & Bussières, J.-F. (2015). Unlicensed and off-label drug use in children before and after pediatric governmental initiatives. The Journal of Pediatric Pharmacology and Therapeutics, 20(4), 316–328. Web.
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. The Journal of Pediatric Pharmacology and Therapeutics, 20(3), 186–196. Web.
Rodwin, M. (2015). Managing off-label drug use [Blog post]. Web.
Wittich, C. M., Burkle, C. M., & Lanier, W. L. (2012). Ten common questions (and their answers) about off-label drug use. Mayo Clinic Proceedings, 87(10), 982–990. Web.