One example is the use of medications to treat depression in children. Data indicate that psychiatric emergencies are on the rise for children and adolescents, yet there is only one medication, fluoxetine, approved for pediatric use. Still, others are frequently prescribed. The dosages, efficacy, and safety of these medications have not been well established for pediatric patients. Although there is some evidence that one of those drugs, paroxetine, may lead to an increased risk of suicide, the research is thin, and it is unclear why there is a greater risk associated with this and other drugs in comparison with fluoxetine.
Medications designed for adults may not be suitable for children because of differences in pharmacokinetics (what the body does to a drug) and pharmacodynamics (what a drug does to the body). Children’s bodies absorb, distribute, metabolize, and eliminate medications differently from those of adults. But pharmacokinetics and pharmacodynamics also differ as children develop, so the needs of a premature infant, full-term infant, child, and adolescent can vary greatly. A good example is morphine. To achieve a morphine steady-state serum concentration of 10 nanograms (ng)/ml, the infusion rate in micrograms (µg)/kg/hr is 5 for neonates, 8.5 at 1 month of age, 13.5 at 3 months, 18 at 1 year, and 16 at ages 1–3 after noncardiac surgery in an intensive care unit (ICU) (Bouwmeester et al., 2004).
Currently, emergency care professionals have little by way of evidence-based guidelines and information to assist them with the prescribing of medications for infants, children, and adolescents (Mace et al., 2004). For example, there is currently no consensus on optimal guidelines for medications for pediatric sedation; in fact, sometimes these medications are given to children in combination with other drugs. Adverse drug events are common, particularly for antibiotics (e.g., ceftriaxone, clindamycin, amoxicillin), opioids (e.g., morphine, hydromorphone, acetaminophen with codeine), and anticonvulsants (e.g., phenytoin, phenobarbital, valproic acid); drugs in these classes are commonly prescribed to children in an emergency setting. Because of the startling knowledge gap and the frequent use of medications in children in the emergency setting, the committee recommends that the Department of Health and Human Services fund studies of the efficacy, safety, and health outcomes of medications used for infants, children, and adolescents in emergency care settings in order to improve patient safety (5.1). A number of different agencies within the Department of Health and Human Services (DHHS) could lead this effort, including the FDA, the Health Resources and Services Administration (HRSA), and the Agency for Healthcare Research and Quality (AHRQ). Congress has already taken some action in this area by passing two laws that provide incentives for or require drug manufacturers to conduct studies on the effects of drugs when used for pediatric patients—the Best Pharmaceuticals for Children Act of