Off Label Medications for Pediatrics
Pediatrics
Off-Label Drugs Background Off-label drug use continues to be a vital public health issue, specifically for infants, young children, and children with a rare diseases. These medications have not been formally studied and approved by the Food and Drug Administration (FDA) to be safe for use in the pediatric population, which is determined based on a demonstration of the efficacy of inadequate, well-controlled clinical trials. Much work still must be done to ensure the best possible practice for therapeutic decision-making in pediatrics (American Academy of Pediatrics, 2014). Consequently, medications used for treating children are inadequately documented regarding dosage, safety, side effects, and efficacy of the medication (Saiyed et al., 2015). This discussion post will address circumstances in which children should be prescribed drugs for off-label use, safer strategies that promote off-label usage, and names of drugs that require extra care and attention when administered to pediatrics.
Pediatric Off-Label Drug Use: Certain Circumstances
According to Bazzano et al. (2009), off-label prescribing occurs when a child receives a medication that has not received FDA approval for the childs age or diagnosis. Although the overall purpose of prescribing an off-label usage drug is to benefit the recipient of the drug, the use in many cases has not been approved for pediatrics or received appropriate research for the intentions provided. Under certain circumstances, children are more likely to receive off-label medications due to few drugs being tested or approved in the young population, which gives the practitioner limited choices for medicines approved for treatment. Another reason children should be prescribed drugs for off-label use is when the benefits outweigh the risks in administering the medications to the pediatric population (Neville, 2014). Off-label medications are often prescribed in primary care and hospital settings. The most used off-label drugs in the hospital care setting were analgesics and antibiotics (Saiyed et al., 2015). Other everyday off-label drug use in the pediatric hospital setting included: morphine, Proventil, caffeine, Tylenol, and topically administered drugs such as dermatological ointments and eye drops (Kimland & Odlind, 2012). According to Neville (2014), pediatricians must prescribe off-label drugs because an overwhelming number of critical drugs still have no information on the label for use in children.
Safer Strategies: Off-Label Drug Use
Regarding safety, it is always important to monitor the safety of medications in general, but especially with children. When considering a dosage, the difference varies significantly from medications needs in pediatrics instead of medication needs in adults. The practitioner needs to understand the pharmacokinetic response to a drug that deals with the safety of drug dosages. The drugs absorption, distribution, metabolism, and excretion are different in how children and adults respond to the drugs due to growth and maturation (Arcangelo, Peterson, Wilbur, & Reinhold, 2017). To make the off-label use of drugs safer, there need to be stricter guidelines due to the fact that the FDA does not explicitly regulate off-label use of medications. Another strategy to promote safer dosages of drugs in pediatrics includes the practitioner prescribing a dosage formulation not commercially available to seek assistance from a pharmacist knowledgeable about accurate pediatric drug dosages and formulas (Arcangelo, Peterson, Wilbur, & Reinhold, 2017). It should also be recommended that the drug manufacture company provide extensive studies and documentation before a drug can be approved and placed on the market for use with proper studies available.
Descriptions/Names: Pediatric Off-Label Drugs
There are many drugs listed that include off-label drug usage in pediatrics that require extra care and attention. Albuterol is a bronchodilator that relaxes muscles in the airways and increases airflow to the lungs (Drugs.com, 2012). When used in pediatrics, Extra care is needed because it has been found ineffective or has serious side effects when systemically studied (Bazzano et al., 2009). Amoxicillin is an anti-infective that should be used in care with pediatrics due to ineffective testing to determine specific outcomes when used in children (Drugs.com, 2012). Promethazine is indicated for nausea and vomiting; however, a black box warning was issued for children under two years of age due to respiratory depression and death (Bazzano et al., 2009). Paroxetine is an antidepressant that has been black-boxed due to suicide in children, so the administration of this drug should be monitored closely (Bazzano et al., 2009). These are all various types of medications used in pediatrics that should be prescribed with extra care and caution, in which the risk and benefits should be determined when used in pediatrics.
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