Our smallest patients are the most vulnerable to medication errors. An awareness of potential vulnerabilities when prescribing in this population is essential.
— Ann M. Dietrich, MD, FAAP, FACEP, Pediatric Emergency Medicine1
Medication safety is critical in pediatric patients because they are especially vulnerable to medication errors. In the two decades since the Institute of Medicine [IOM] released its landmark report, “To Err is Human: Building a Safer Health System,” with recommendations addressing medication errors, the focus on medication safety continues.2 The focus on safety in the pediatric population is essential because most medications used in these patients have never been tested in them.3 Before the U.S. Food and Drug Administration’s [FDA] pediatric program was initiated in 2002, about 20% of all FDA-approved drugs carried pediatric labeling. Between 2002 and 2014, 500 changes in pediatric drug-labeling updates were made,4 with an estimated half of all drugs used in this population containing pediatric labeling.4 Progress continues with labeling changes reaching more than 850 by April 2020.5 For drugs without pediatric labeling, prescribers are using these medications “off-label” based on “sound scientific evidence, expert medical judgment or published literature whenever possible.”6 While many medications have been on the market a long time, without testing and subsequent labeling, there may be unknown factors that can contribute to medication errors and adverse events because drug efficacy, toxicity and pharmacokinetics are different in the pediatric population. This lesson focuses on medication safety in the pediatric population and strategies pharmacists and pharmacy team members can consider implementing to prevent medication errors.
Medication Errors and Pediatric Patients
Twenty-two percent of the U.S. population are under 18 years of age, the pediatric population.7 It is important to use standard age definitions when caring for pediatric patients. See Table 1 for the age associated with preterm, neonate, infant, child and adolescent.8
Table 1. Pediatric Age Definitions8TerminologyAgePretermBirth [greater than]