Explain the circumstances under which children should be prescribed drugs for off-label use. Be specific and provide examples.
Describe strategies to make the off-label use and dosage of drugs safer for children from infancy to adolescence. Include descriptions and names of off-label drugs that require extra care and attention when used in pediatrics.
Week 11 Discussion
Off-label Use of Drugs
Off-label use refers to the unapproved use of an approved drug. This implies that a drug is either used for a medical condition or disease that it is not approved to treat, such as when a drug that is approved for the treatment of one cancer being used to treat another cancer, used in a different way, such as when a capsule drug is used as an oral solution or used in a different dose, such as when a drug that is approved at a two-tablet dose is given to a patient as a single tablet every day (Mayhew, 2009). Off-label drug use might be used because there is no approved drug for treating a medical condition or disease. It may also be used when all approved treatments and drugs have been tried and there are no benefits observable. Off-label drug use can be safe since the fact that a disease or patient category is not included on a drug label does not mean that a drug is not appropriate for that use. It only means that the authority (FDA) has not approved a particular use of the drug, but it may be appropriate.
Off-label use is an important part of contemporary medicine as many patients benefit when they are given prescriptions under circumstances that are not specified on the label approved by the FDA. For children, off-label use has the capability of providing the best medical intervention. For the children population, off-label use may even be the standard of care for specific health problems. Most of the drugs that are prescribed to children are used off-label since drugs are rarely tested in that age group. The practice is an accepted medical practice that is reasonable when there exists scientific or medical evidence that a certain drug is effective for a certain medical application.
In a state of perfection, all drug use should be supported by research. In reality, however, the medical community finds itself with the duty to determine when the use of off-label prescriptions is appropriate to help patients (Mayhew, 2009). To ensure safety when giving off-label prescriptions, the use of research methods is an important strategy for medical practitioners. Pharmaceutical companies should fund research and publish journals to improve best practices in off-label prescriptions. As Bazzano et al. (2009) state, “Research and policy interventions may benefit from understanding which children receive which medications off-label”. This is only through medical research on children to determine which off-label drugs are appropriate. National consortium and pediatric drug studies should be conducted rationally to improve drug use safety.
All children have the right to receive effective and safe medicine in the correct dosage, indication, and route of administration. While off-label use of drugs can be beneficial, it is sometimes associated with negative drug reactions in children (Horen et al., 2002). Respiratory and psychiatric drugs are the most common drugs that are prescribed off-label in children. An example of a commonly used drug is Sertraline (Zoloft), a selective serotonin reuptake inhibitor (SSRI) antidepressant (Arcangelo et al., 2017). It is usually given to children with OCD. Loratidine (Claritin) is also a commonly used drug, an antihistamine that minimizes the effects of histamine in the body. It is commonly used in children for allergic rhinitis and urticaria (Arcangelo et al., 2017). While using these drugs to treat children, it is important to weigh the potential risk versus the clinical need.
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.
Bazzano, A. T, Mangione-Smith, R., Schonlau, M., Suttorp, M. J., & Brook, R. H. (2009). Off-label prescribing to children in the United States outpatient setting. Academic Pediatrics, 9(2), 81-88.
Horen, B., Montastruc, J. L., & Lapeyre-Mestre, M. (2002). Adverse drug reactions and off-label drug use in paediatric outpatients. British journal of clinical pharmacology, 54(6), 665.
Mayhew, M. (2009). Off-label prescribing. The Journal for Nurse Practitioners, 5(2), 122-123.
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