Caring for the pediatric population requires distinctive care and precise prescribing of
medications.
Virtually all drugs that get an approval for use in adults should also get an approval
for use in children (Corny et al, 2015).
Unfortunately, this is not the case due to the lack of
clinical research for the pediatric population (2015).
The research process of drugs in children is
complex due to the balance between advantages and risks, consenting, the necessity to provide
an appropriate drug formulation, the pharmacokinetics/pharmacodynamics particularities, and
the parent’s intervention (2015).
Without approval from the U.S. Food and Drug Administration
(FDA) or adequate documented information, many practitioners are uncertain how to use drugs
in pediatrics (Arcangelo et al, 2017a).
Prescribers are left with little choice but to use drugs in
pediatric patients in an off-label capacity based on adult data (2017a).
Fortunately, the practice
of off-label prescribing is considered reasonable if it is based on sound clinical evidence (Panther
et al 2017b).
According to the American Academy of Pediatrics (AAP) (2014), a drugs off-label
status does not imply an improper or experimental use.
The practice of off-label prescribing for pediatric patients predisposes children to
medication errors as doses must be calculated on an individual patient basis, often in the absence
of appropriate dosing information from the pharmaceutical manufacturer (Tefera et al, 2017c).
Studies have shown that medication errors are three times more likely in pediatrics than adult
patients (2017c).
To assist in decreasing the incidence of off-label prescribing in the pediatric
population, the FDA Safety and Innovation Act (FDASIA) now requires pharmaceutical
companies, in most circumstances, to create pediatric drug/biologic developments programs
before Phase 3 (pivotal) adult efficacy and safety trials are underway (Karesh, Tomaino, &
Mulberg, 2013).
The goal of considering pediatric research relatively early in the development
process is ultimately to improve children’s access to medicines that have been appropriately
studied for the management of their diseases (2013).
In addition, two key laws, the Best
Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA), work
together to improve pediatric information in medication labeling (2013).
Pediatric studies
conducted under these laws are helping to generate much-needed information about the use of
medications in pediatric patients and addressing the issues of off-label medication use in the
pediatric population (2013).
Under these laws, there have been findings including important
negative or inconclusive results that are described in product labeling (2013).
Attention-deficit/hyperactivity disorder (ADHD) is currently diagnosed in approximately
11% of United States children ages 4 to 17 years of age, but the majority of medications are not
indicated for children 6 years of age and under (2017b).
Atomoxetine has not been studied in
children ages 3 to 4, but is often prescribed (2017b).
There is concern regarding potentially
