Medication administration in pediatrics is a complex process. The Institute for Safe Medication Practices identified several factors in the medication system that contribute to error and increased risk for adverse drug events in children. There is a lack of published information or FDA approved labeling regarding dosing, pharmacokinetics, safety, efficacy and clinical use of drugs in the pediatric population. Pediatric clinicians often must perform complicated calculations for individual doses based on page, weight, body surface area and clinical condition. Dosage forms and concentrations appropriate for administration to neonates, infants, and children are not always available and dosage formulations are often extemporaneously compounded. This requires nurses and pharmacists to calculate and prepare dilutions from adult unit-dose packages for intravenous medications as well as provide precise dose measurement and appropriate drug delivery systems.
Furthermore, because of the different and changing pharmacokinetic parameters between patients at various ages and stages of maturational development, children are at increased risk for adverse drug reactions. Young children cannot serve as a check on the medication administration system. They cannot recognize if a preparation of a medication is different from previously prescribed or describe side effects that might serve as an early warning sign of potential harm. Pediatric patients are therefore especially vulnerable for adverse events from high alert medications.
Adverse drug events (ADE’s) are injuries from medications or from the lack of an intended medication. Hospitalized children are at risk for ADE’s because of their developmental variability and their exposure to medications during a hospitalization. Several studies have estimated the burden of ADE’s for pediatric patients. Holdsworth et al. found an ADE rate of 6/100 admissions or 7.5/1000 patient days and a potential ADE rate of 8/100 admissions or 9.3/1000 patient days. Kaushal et al. described ADE rates of 2.3/100 admissions or 6.6 per 1000 patient days and potential ADE rates of 10/100 admission, 29/1000 patient days.
Holdsworth, MT, Richtl, RE, Behta, M et al (2003). Incidence and impact of adverse drug events in pediatric inpatients. Archives of Pediatric and Adolescent Medicine. 157:60-65.
Kaushal, R., Bates, DW, Landrigan, C et al. (2001). Medication errors and adverse drug events in pediatric inpatients. JAMA 285, 16: 2114-2120.
