Off-Label Drug Use in Pediatrics
There is a current high rate of off-label drug use in children. In the United States, the regulations of the Food and Drug Administration (FDA) permit physicians to prescribe approved medications for other than their intended indications which are known as off-label use (Shiel, 2016). There has been a lack of clinical trials or research involving medications for children. This has resulted in the non-availability or unsafe prescribing of treatment options, which contain many safety risks.
All medication labels contain details for drug use, such as target population, dose, indication, and specific purpose. The potential harm of the use of off-label drugs was the increase in adverse drug reactions, followed by an increased risk of medication errors associated with insufficient labeling (Corny et al., 2015). Children should be prescribed off-label drugs only if it is in the best interest of the patient and contains minimal risks involved. The intended use of the drug should also be known.
Off-label prescribing is highly prevalent in children with dose and frequency, often being factors changed. Among children ages, 3 to 5 years, 91.4% of prescriptions were off-label (Panther et al., 2017). Common off-label uses of drugs in children include antibiotics, analgesics, antidepressants, bronchodilators, and psychostimulants. With regards to antidepressants, children have experienced an increased risk of suicide due to off-label drug use of antidepressants. According to Panther et al., (2017), children with attention deficit hyperactivity disorder (ADHD) were prescribed off-label medications primarily at the ages of 5 years and younger. Sudden cardiac death and adverse psychiatric effects are a concern with the use of psychostimulants in the treatment of ADHD (Arcangelo et al., 2017). With all off-label drug use, the risk toxicity is high due to impaired elimination. All patients and guardians should be communicated the risks and information on potential side effects before given the medication.
Pharmacists should be used as resources when prescribing off-label drugs. Pharmacists have a positive effect on the preparation and administration of medications by reducing medication errors. Also, children with chronic illness requiring regular or continuous medications, referral to a specialist will help achieve desired medication outcomes while minimizing risks to the patient. All medicines prescribed to children should be based on recommended guidelines, clinical judgment, professional resources utilized, and benefits must outweigh the risks.
According to Corny et al., (2015), it challenging to research pediatrics due to the advantages and the risks, the consent issues depending on the age, the necessity to provide an appropriate drug formulation, the pharmacokinetic/pharmacodynamic particularities, and the parent’s intervention. An increase in governmental initiatives needs to be given to improve clinical research conducted in children. Governmental agencies, pharmaceutical companies, funding institutes, and research centers, should work altogether to support and facilitate drug research in children. The increase in clinical research can decrease the use of off-label drugs. Safety, efficacy, and quality of each drug should be tested before prescribing to an individualized or specific population.
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